講演者

Dr. Frank Agbogbo has over 18 years of experience in process development, biotechnology, gene, and cell therapy industries. He is currently the Vice President of Process Development at Forge Biologics, responsible for rAAV process development and plasmid DNA production. Previously, Dr. Agbogbo was the Senior Director of Process Development at Cytovance Biologics for over 7 years where he took increasing responsibilities as Director of Process Development with oversight responsibilities over the Upstream and Downstream teams. Frank’s experience includes process development, Design of Experiments (DoE), process optimization, process characterization, and scale-up from R&D to manufacturing (cGMP and non-cGMP). He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. He holds a Bachelor of Science in Chemical Engineering, PhD in Chemical Engineering from Texas A&M University, College Station, TX, and an MBA with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University, OK.

• Gene Therapy Manufacturing

Raquel Aires-Barros is a Full Professor at the Department of Bioengineering at Instituto Superior Técnico (IST) and Senior Researcher at Institute for Bioengineering and Biosciences (iBB), Associate Laboratory i4HB—Institute for Health and Bioeconomy. She is a Chemical Engineering from IST, with a MSc in Biochemical Engineering and a Ph.D. both at IST. Was a Research Assistant in Massachusetts Institute of Technology from 1986-1987. Coordinates the scientific-pedagogical area of Biomolecular and Bioprocessing Engineering of Bioengineering Department at IST and is Vice-President of IST School Board. Current research interests include the development of new separation processes with high performance and efficiency for purification biopharmaceuticals, with special emphasis on the purification of antibodies and the development of devices- "Lab-on-a-Chip" - for protein purification / separation of cells in the microscale. She is chair of the Session of Downstream Processing (DSP) of the European Society of Biochemical Engineering Sciences (ESBES), President of the Portuguese Society for Biotechnology and editor of Separation and Purification Technology Journal. Has been involved in the coordination/participation of several European projects, and in Scientific and Organising Committees of International Conferences in the area of bioseparation. Supervised more than 70 master’s and PhD dissertations and is author of more than 250 papers and book chapters.

• Advances in Recovery and Purification - Part 1

Paula M. Alves is the CEO of iBET and Professor at NOVA University of Lisbon. She received her Ph.D. in Biochemical Engineering from NOVA and her B.S in Biochemistry from the University of Lisbon. Working in Animal Cell Technology since 1990, her research integrates cell metabolism understanding with biochemical engineering for the improvement of bioprocesses efficiency, also focusing on the development of new tools and technologies for pre-clinical research. Her key areas of interest include the production of biopharmaceuticals such as viral vectors and vaccines, and the development of 3D culture systems for expansion and differentiation of stem cells in bioreactors for cell therapy, regenerative medicine and in vitro toxicology applications. Professor Paula Alves was elected member of the US National Academy of Engineering in 2021 and was the Chairperson of the ESACT (European Society for Animal Cell Technology) from 2017 to June 2022. Paula Alves is currently a Member of the International Advisory Committee of the Center for Research and Development of Immunobiologicals – CerDI (Instituto Butantan, Brasil) and SAB Member of IABS (International Alliance for Biological Standardization (IABS) Endowment Fund Committee, France. At the European Commission she was member of IMI and EURL-ECVAM Scientific Advisory Committee and of the Advisory Board of Horizon 2020 Societal Challenge. She has published over 310 papers, 32 book chapters and has supervised 40 PhD students, 18 post-docs and several master theses. In 2009 she received the Scientific Merit Award from NOVA University of Lisbon, in 2021 the Gold medal of Oeiras Town and in 2024 the ECI Cell Therapies Award.

• Cell Therapy CMC and Manufacturing

After performing my Master thesis in Molecular Biology at the University of Basel, Switzerland, I joined Novartis in 2009 as a Scientist in protein purification. Working at the interface of research and development I'm currently responsible for the production and purification of various biotherapeutic formats to support Developability Assessment and candidate selection.

• Advances in Recovery and Purification - Part 1

As the Executive Director - Drug Product Design & Development, Advait leads the organization within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization focused on identifying and developing formulations and processes to support Pfizer’s entire biotech & vaccine portfolio with accountability for novel delivery technologies, adjuvant vaccines, RNA-based modalities, and microbial and mammalian produced proteins. The focus is on all things related to Drug Product from the early Research stages up to Licensure, including Commercial and Life Cycle Management support. In his role as Head of Nanoparticle Development, Advait’s accountability includes scientific, technical, strategic, and regulatory leadership of Pfizer’s mRNA/LNP and nanoparticle-based portfolio. Advait is accountable for establishing internal capabilities and expertise for formulation, process development, scale-up, and tech transfer to enable clinical and commercial supplies. In addition to this, there is a focus on external strategic alliances and collaborations. Advait received his Ph.D. in Pharmaceutical Sciences from the College of Pharmacy and Health Sciences, Mercer University (Atlanta, GA) and a MS in Pharmaceutics from Auburn University, Auburn, AL. He also has a BS in Pharmacy from Pune University (India). He is a member of AAPS and Controlled Release and is an inventor on more than 10 patents, published over 30 articles in professional scientific journals, and presented more than 50 short papers, posters and talks.

• Gene Therapy CMC and Analytics

Selina Bäder is a Senior Associate in the Nucleic Acid Sciences Team within the Cell and Gene Therapy Department at Roche. Her primary focus lies on developing and optimizing purification processes for plasmid DNA used for in vivo Gene therapeutics. Before joining Roche Selina completed her Bachelor and Master degree in Pharmaceutical Technology at the University of Applied Sciences Biberach and the University Ulm, Germany.

• Gene Therapy CMC and Analytics

After completion of a first degree in Chemical Engineering/Biotechnology (FHO Emden, Germany) he carried out a PhD in Applied Molecular Biology at UMIST (Manchester, UK). Following a short postdoctoral period in the Department of Biochemical Engineering at UCL he became a Lecturer in 1999 and currently holds a position as Associate Professor. He has an established track record in modelling, engineering and scale-up/down of fermentation and cell culture processes. In recognition for his contributions to the development of miniature bioreactor technologies he received the 2010 Pharmaceuticals Division Plenary Award of the AIChE. He has published over 80 papers and co-authored 4 book chapters.

• AI and Process Control
• Gene Therapy Manufacturing

Dr. Janina Bahnemann is Full Professor and the Department Head of “Technical Biology” at the University of Augsburg. She obtained her PhD from Hamburg University of Technology and joined the California Institute of Technology (USA) as a postdoc in 2015. Afterwards, she led an independent Emmy Noether (DFG) research group at Leibniz University Hannover, and held a substitute professorship at Bielefeld University. Her research focuses on cell culture and microsystems technology and the development of biosensors for biotechnological and biomedical applications.

• Accelerating Analytical Development

Dr. Barros is a biophysicist with expertise in biomolecular interactions working in drug product development. She received her PhD from Carnegie Melon University Physics where she studied biomolecular interactions and structure of proteins at lipid membranes. During her graduating studies she became a Guest Researcher at NIST Center for Neutron Research where she conducted neutron scattering experiments. After her PhD, she joined Dr. Yueming Li at MSK as a postdoc to lead and develop the lab biophysics research for studying the mechanisms of action of proteins that have implication in both cancer and Alzheimer disease. Currently, she works for Bristol Myers Squibb as a Research Investigator investigating the colloidal stability of biotherapeutics to support drug development and new strategies of drug product formulation.

• Gene Therapy CMC and Analytics

Iris L. Batalha is currently a Junior Leader Research Fellow at the Institute of Bioengineering of Catalonia (IBEC) in Barcelona, a Panel Tutor in Nanotherapeutics at the University of Cambridge Institute of Continuing Education, a freelance Senior Innovation Consultant at Inspiralia (Spain and USA), a Co-Founder, Director and Editor-in-Chief of the non-profit organisation Women Ahead of Their Time (WATT), and a Research Associate at Peterhouse College. From 2017 to 2020, she was a joint Research Associate at the Department of Engineering Nanoscience Centre and Department of Medicine Molecular Immunity Unit, University of Cambridge. From 2014 to 2017, she worked at the Department of Chemical Engineering and Biotechnology, University of Cambridge, and the biopharmaceutical company MedImmune/AstraZeneca, followed by a brief experience as a healthcare/pharmaceutical consultant. Her research interests and expertise lie in medical and pharmaceutical research and development, particularly in the fields of nanobiotechnology, bio-inspired materials, downstream processing, formulation, and drug delivery.

• Next-Generation Analytical Methods

Niels, a staff scientist within the Roche pRED Large Molecule Research organization, applies insights from the interdisciplinary field of synthetic biology to improve the manufacturing capabilities of CHO biofactories. He has contributed to the development of state-of-the-art CHO biofactories, which ensure optimal production of heterodimeric bispecific antibodies through rational genetic engineering, CRISPR/Cas9 functional screenings, and the introduction of genomic barcodes for cell lineage tracing. His work revisits and updates CHO cell engineering options in the context of isogenic targeted integration cell line development.

• Cell Culture and Cell Line Engineering - Part 2

Mark is the leader of upstream process development at Purespring Therapeutics and has 15 years of industrial experience within the cell and gene therapy sector. Mark leads a team of experienced scientists within the viral gene development, delivering robust manufacturing processes, supported by rapid, high-resolution characterization tools to enhance the production of AAV based gene therapies. Mark's team also supports the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture. Prior to his work at Purespring, Mark spent 7 years at the Cell and Gene Therapy Catapulting supporting the development of ATMP processes suitable for GMP as well as consulting for the Janssen group advising on the manufacture of its lead ocular gene therapy.

• Gene Therapy Manufacturing

Bassem Ben Yahia is part of Upstream Process Sciences Group at UCB Pharma in Belgium since 2011 and is focusing on innovative cell culture technologies, media development, process optimization, process intensification and process modeling. Passionate about biology and modelling biological systems, Bassem holds a PhD degree in Biochemistry & Biochemical Engineering from University of Saarlandes in Germany focused on predictive macroscopic modeling of Chinese hamster ovary cells in fed-batch processes. During his PhD, he successfully developed a simple and robust modeling methodology to predict cell culture performances which is currently used at UCB to accelerate early stage process development.

• Cell Culture and Cell Line Engineering - Part 1

Prof. Sonja Berensmeier has led the Bioseparation Engineering Group at the Technical University of Munich since 2009. Previously, she worked as a group leader at the Karlsruhe Institute of Technology in the area of biofunctional surfaces. She meets the challenge of integrating molecular biology, biotechnology, particle technology, and process engineering. Her current research focuses on process intensification by adsorptive and extractive separation methods. In the field of adsorbents, she specializes in magnetic and conductive materials and their translation into new process designs. Berensmeier gained international experience at MIT, ETH, and Iowa State University. She is well established in the scientific community and is a member of the scientific committees of the international conferences PREP and ISPPP.

• Advances in Recovery and Purification - Part 1

Martin Bertschinger completed his Ph.D. at the EPFL in Lausanne (Switzerland) in the Laboratory of Professor Florian Wurm. After finishing his Ph.D. in 2006, Martin joined Glenmark Pharmaceuticals SA (Switzerland) in order to build teams for protein expression and cell line development. In 2019, Glenmark Pharmaceuticals span out its R&D unit into Ichnos Sciences. At Ichnos Sciences, Martin is leading the Drug Substance Development department (Cell Line Development, Upstream and Downstream Process Development).

• Cell Culture and Cell Line Engineering - Part 1

Thierry Besson obtained his master’s degree in analytical chemistry at the University of Rennes – France in 2005. I always used mass spectrometry in the different laboratories I joined, starting at Servier for the structure elucidation of small molecules, then in a fundamental lab research facility in Paris to perform infrared spectroscopy in gas phase. I joined Novartis Institutes for Biomedical Research, in 2008, in Patrick Schindler’s lab in the Novartis Biologics Center (NBC), where I started to do characterization of biomolecules by mass spectrometry. First on classical antibodies and then followed by all other kinds of difficult formats to analyze such as bispecific, fusion-protein, therapeutic proteins, ADC, and more recently with Adeno Associated Viruses, Radio Ligand Therapy and oligonucleotides mAb conjugates.

• Next-Generation Analytical Methods

Having completed my PhD in Biophysics from the University of Osnabrueck, Germany, in 2012, I carried out my first postdoctoral stint at the Department of Bioengineering, UC Berkeley, USA, where I focused on conformational dynamics of intrinsically disordered proteins. In 2015, I moved back to Germany and joined the Institute of Biochemistry, University of Muenster. Here, with support from an Alexander von Humboldt postdoctoral fellowship, I developed intein-based technologies for application in chemical biology. Since 2020, I have been a part of the Large Molecule Research (LMR) unit at pRED, Roche, where I have been delving into different aspects of biotherapeutic discovery and development, with a focus on biochemical and functional characterization.

• Accelerating Analytical Development
• Process Modelling and Developability

Jake is a Consultant at Syner-G BioPharma Group, where he serves as an Analytical and CMC expert. His diverse knowledge base spans a range of chemistry fields including synthetic organic, analytical, chemometrics, and nanomaterials . Jake’s expertise in a variety of spectroscopic methods and data analysis, coupled with his CMC and regulatory experience, provides a unique insight into the constantly evolving world of analytical/bioanalytical method development and validation. Jake obtained his PhD in Organic Chemistry from Yale University as an NSF Graduate Research Fellow. His academic research focused on medicinal chemistry and the development of new spectroscopic methods, fields in which he has authored multiple papers.

• Accelerating Analytical Development
• Process Modelling and Developability

Ignasi is a data scientist with over five years of experience in the pharmaceutical industry. Since 2021, he has been working at Körber Pharma, assisting biopharmaceutical companies in achieving successful product submissions in accordance with QbD principles and regulatory compliance. In 2024, he began an industrial PhD at RWTH Aachen, focusing on the integration of physics-informed deep neural networks into end-to-end digital twins. Prior to joining Körber, Ignasi developed expertise in machine learning and hybrid modeling tools and made significant contributions to industrial scale-up projects in various start-ups.

• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 1

Jonathan holds a PhD in analytical chemistry from Dublin City University and an MBA from University College Dublin. He is principal investigator of the Characterisation and Comparability Laboratory at NIBRT, director of CONCEPT, NIBRT’s new early-stage research core facility and an associate professor in the school of chemical and bioprocess engineering at UCD.

• Next-Generation Analytical Methods

As an analytical scientist at Roche Pharmaceuticals for 10 years in Germany, Lea develops on- and offline liquid chromatographic and mass spectrometric methods for the analysis of therapeutic proteins, providing identification, characterisation, quantitative and/or structural information. Lea was born in New Zealand where she completed her Bachelors and Ph.D, both focusing on environmental analytical and synthetic chemistry. Her Masters was completed in Marine Natural Product Chemistry in Okinawa, Japan and in Spain the focus of her Postdoc was also in the environmental analytical field. Prior to Roche Pharmaceuticals, Lea worked at LC-MS method and instrument suppliers covering small molecule applications for clinical, diagnostic, environmental and forensic fields.

• Accelerating Analytical Development
• Process Modelling and Developability

PhD in Drug Sciences with specialization in monoclonal antibody development and biosimilars. Experienced in CHO cell line development, process optimization, and analytical techniques. Consultant for a biopharmaceutical company providing CDMO services, supporting clients in the production of biosimilars. Skilled in regulatory compliance, project management, and mAb characterization.

• Cell Culture and Cell Line Engineering - Part 2

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor and the Director of the Center for Continuous mRNA Manufacturing at the Massachusetts Institute of Technology (MIT). He leads the modeling, control, and systems activities in many biopharmaceutical manufacturing efforts at MIT, including for vaccines, gene therapy, and monoclonal antibodies. Most activities are in automated process development workflows and modeling, design, and control of fully automated modular manufacturing unit operations and end-to-end systems, which are experimentally validated. He has consulted or collaborated with more than 25 companies including Novartis, Pfizer, Merck, Biogen, Sanofi, and Amgen. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Separation Division Innovation Award, the AIChE Excellence in Process Development Research Award, the Research Collaboration Award from the Council for Chemical Research, and the IEEE Control Systems Society Transition to Practice Award. He is a member of the National Academy of Engineering.

• Intensified and Continuous Processing

Alexander Buettner obtained his Ph.D. from TUM in 2016, focusing on enhancing E. coli antibody fragment expression systems at Boehringer Ingelheim Vienna. He began his professional journey at Roche as a Postdoctoral Researcher in 2016, contributing to glycan structure function studies for Neorecormon and Mircera. Over the years, he has progressed to the roles of Scientist (2017), Group Leader (2019), and Senior Scientist (2021), where he has been involved in various areas including routine (extended) characterization of biopharmaceuticals, Data Science topics, IT system validation, instrument qualification, method validation, and automation of sample preparation.

• Accelerating Analytical Development

I’m pursuing an EngD in Biochemical Engineering at UCL, focused on investigating the mechanisms behind extracellular vesicle (EV) subpopulation isolation during ion exchange chromatography using Astrea Bioseparations’ nanofiber-based adsorbent. My goal is to provide insights that support the development of more improved bioprocesses with greater recovery, purity, and product quality.

• Advances in Recovery and Purification - Part 2

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

• AI and Process Control
• Cell Culture and Cell Line Engineering - Part 2

Prof. Dr. Johannes Buyel is a biotechnologist and bioprocess engineer and by training and received his Bachelor of Science from the RWTH Aachen University in Aachen (one of Germany´s Excellence Universities) in 2006. He continued his master studies in Molecular Biotechnology with stays abroad in Sweden (Lund University, ERASMUS schoolarship) and the USA (Fraunhofer Center for Molecular Biotechnology, Newark, Delaware). Finishing his Masters with honours in 2009 he was awarded the Springoroum Coin. Johannes conducted his PhD at RWTH Aachen University during which he was a visiting scientist at the Rensselaer Polytechnic Institute (Troy, NY, USA) and Karlsruhe Institute of Technology (KIT) (Germany) for several months. He received his PhD with honours and was awarded the Borchers Medal. In 2014 he joined Fraunhofer IME as a group leader and became head of the Bioprocess Engineering department the year after. In parallel, Johannes started a second PhD in Bioprocess Engineering at the KIT, which he finished in 2017. Between 2018 and 2020 he conducted his habilitation and was an Associate Professor at the RWTH between 2020 and 2023. Johannes is an active member of the German Biotechnology Association (DECHEMA), and member of the Editorial Boards of Frontiers in Bioengineering and Biotechnology, Frontiers in Plant Science as well as Transgenic Research, where he is Editor-in-Chief since 2021. In 2022, he joined the University of Natural Resources and Life Sciences, Vienna (BOKU) as a Full Professor for Downstream Processing. Johannes has 15+ years of experience in the development of tailor-made upstream production and downstream processing for 50+ recombinant proteins, small molecules and DNA in different expression systems such as E. coli, yeast, plant cell cultures and whole plants both under GMP and non-GMP conditions. He is also focussing on integrated processing, i.e. the use of residual biomass for cascading use. Johannes was/is involved in international projects like PHARMAPLANT, FUTURE-PHARMA and RESILIANCE. Amongst others, he received a €2.5 million Fraunhofer Attract grant for a project to establish a model-driven high-throughput expression and purification platform for recombinant proteins (FAST-PEP). Johannes was a principal investigator (PI) in the tumor-targeted drug delivery graduate school of the German Research Foundation (DFG; 2018-2022) as well as the International Center for Networked Adaptive Production (ICNAP; 2016-2022) for which he has so far received funding of €0.9 million and €1.8 million respectively. His work is strongly inter- and cross-disciplinary, combining research in, for example, biotechnology, bioprocess engineering, informatics, mathematics, data science, oncology, cosmetics and nutrition. He has currently more than 80 publications (h-index 27, i10-index 51, 2333 citations as of August 2023).

• Advances in Recovery and Purification - Part 2

Expert (20+ years) in CMC activities for pre-clinical, early and late stage clinical development, formulation, analytical development, fill/finish process and manufacturing of peptide, protein, antibody, vaccines, viral vectors, cell & gene therapy. Enthusiast for innovation, enabling drug delivery technologies, project and portfolio management. Specialized in physical and chemical characterization of biotherapeutics using standard and novel (high throughput) methodologies. People/project management responsibilities and scientific contributions during time at CRO and Johnson & Johnson Innovative Medicine. Delivered on various technical and scientific achievements, patents, supported business development, project acquisitions, due diligences, public funding (IMI, BARDA, NIH, BMGF) regulatory filings (IND/IMPD’s for e.g. RSV, HIV, Zika, HBV, HPV, IPV, Uniflu, Alzheimer, ExPEC, Covid-19) and market authorization approvals for Ebola and Covid vaccines (Zabdeno; Mvabea; Jcovden).

• Gene Therapy CMC and Analytics

Vered Caplan CEO Orgenesis Inc, a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care. Orgenesis identifies promising new therapies and leverages its POCareTM Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. Prior to Orgenesis, Vered has been CEO of Kamedis, a company focused on utilizing plant extracts for dermatology purposes. From 2004 to 2007, Ms. Caplan was CEO of GammaCan, a company focused on the use of immunoglobulins for the treatment of cancer. During the previous five years, Ms. Caplan has been a director of numerous companies in the biotech industry, among them: Inmotion Ltd., a company involved with self-propelled disposable colonoscopies; Nehora Photonics Ltd., a company involved with non-invasive blood monitoring and others. Ms. Caplan has a M.Sc. in biomedical engineering from Tel Aviv University specializing in signal processing; management for engineers from Tel Aviv University specializing in business development; and a B.Sc. in mechanical engineering from the Technion-Israel Institute of Technology specialized in software and cad systems.

• Cell Therapy CMC and Manufacturing

Sean Chia is a Senior Scientist at the Bioprocessing Technology Institute (BTI), A*STAR since 2021. His research is primarily focused on the development of novel analytical methods for biotherapeutic developability profiling, in particular next-generation modalities such as bispecific and multispecific antibodies. This is aimed at uncovering the roles of developability traits in influencing safety and efficacy issues, and the rational development of candidates and formulations to improve these characteristics. Prior to his current position, Sean was a Singapore Biodesign Innovation Fellow, and previously worked at a UK biotechnology startup developing antibody-based diagnostic assays. He holds a PhD and MPhil in Chemistry from the University of Cambridge.

• Next-Generation Analytical Methods

Therese Choquette, Head of Analytical Sciences at Tigen Pharma, has a passion for cell therapy, cellular function, and immunology. She holds a PhD in Rheumatology from the Karolinska Institute in Sweden and completed her postdoctoral fellowship at University of Massachusetts Medical School in Worcester, MA, investigating the impact of hyperglycemia in host defense against M.tb. Her career has been focused on cell and gene therapy since 2014 in the space of analytical development, analytical strategy, and quality control.

• Cell Therapy CMC and Manufacturing

Dr. Ana Sofia Coroadinha has a Degree in Biochemistry (University of Lisbon) and a PhD in Gene Therapy performed at Généthon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009 is the Head of Cell Line Development and Molecular Biotechnology Lab at iBET and ITQB-NOVA. She has over 20 years of experience in recombinant viruses and animal cell culture, areas where she has published over 50 peer reviewed papers. Dr. Ana Sofia Coroadinha group research focus on applied virology developing recombinant virus and molecular tools supporting the areas of gene therapy, vaccine development and virology.

• Gene Therapy Manufacturing

Stephan is the Head of Quality Assurance for Dark Horse Consulting and is a Global Quality leader in the pharmaceutical industry for over 21 years, who has broad experience in CGT, biological, ophthalmic, sterile injectable and solid dose manufacture, packaging, and distribution, all in support of both commercial and clinical trial models. Stephan also holds experience in cGMP manufacture, testing, and quality assurance for supply within the US, EU, and the majority of major global regulatory markets. Stephan is an experienced Qualified Person, Responsible Person, and Manufacturers Specials Quality Controller. Having worked for both small CMO scale and large, multinational ‘blue-chip’ pharma, Stephan brings a wealth of technical and leadership experience at both ‘site’ and ‘above site’ roles. Prior to joining Dark Horse in October 2021, Stephan worked within Pfizer and Hospira at various ‘site’ and ‘above site’ leadership and technical roles, including Global Transport Quality Leader (Vaccines, GTx and Traditional supply), EU product release leader, and Regional EMEA Quality Leader. Special activities during this period included supporting the integration of the EMEA regional integration into Pfizer, QMS and product release remediation, and large-scale remediation of a sterile injectables facility located in India and a compounding facility located within the UK. Prior to Pfizer, Stephan worked at Allergan, supporting the manufacture and distribution of both Biologic, Ophthalmic, and a range of alternative IMP dosage forms. Stephan worked as both a Qualified Person, Responsible Person and Manufacturers Specials Quality Controller on both UK and Ireland Licenses. Stephan also worked as both a QC Microbiologist and Quality Officer within Cobra Biomanufacturing supporting a large variety of activities.

• Cell Therapy CMC and Manufacturing

PhD student at the University of Natural Resources and Applied Life Sciences in Vienna (BOKU), I have specialized in performing techno-economic analyses for the EU-funded project "Enzycle," which focuses on recycling plastic via microbial enzymes. More recently I have been working on the "Econti" project where the goal is to develop a fully integrated continuous bio-manufacturing process. Throughout my academic journey, I discovered that my true passion lies in accelerating the green transition by helping innovative businesses scale up and commercialize their technologies. This realization was sparked by reading Bill Gates' book "How to Avoid a Climate Disaster," which motivated me to pursue a career where I could have a tangible impact on sustainability. This led me to join the European Circular Bioeconomy Fund as an investment analyst, where I gained hands-on experience in assessing and supporting sustainable innovations.

• Intensified and Continuous Processing

Niels Delamotte holds a Master’s Degree in biotechnology from the University of Ghent, which he received in 2001. He began his career at Sanofi, where he worked for 14 years in a range of positions within Quality Control & Manufacturing Science and Technology. In his last role at Sanofi, he was the Analytical Lifecycle Management Project Lead for enzyme products at the Geel Facility in Belgium. In 2019, he joined etherna and moved from commercial protein to GMP clinical-stage mRNA manufacturing with the aim of bringing mRNA therapeutics to the clinic. As Director Analytical Development, he is currently responsible for the Analytical Lifecycle programs within etherna on both mRNA Drug Substance and Drug Product formulated in Lipid Nanoparticles. Furthermore, he is a member of the mRNA working party established by the European Pharmacopoeia (Ph. Eur.) Commission which has the task to develop a consolidated strategy for future standards on mRNA vaccines and their components.

• Gene Therapy CMC and Analytics

Felix is a PhD student at Takeda and member of the Bioprocess Engineering Doctoral School at BOKU University (University of Natural Resources and Life Sciences), Vienna. His PhD thesis focuses on environmental sustainability of biologics and the improvement of Green Metrics. Felix has several years of industry experience in downstream process development for recombinant complex proteins. Felix holds a Master's Degree in Medical Biotechnology from BOKU University.

• Intensified and Continuous Processing

I am a PhD student specializing in biomolecular separation engineering, with a focus on DSP and PAT development for virus-like particles. Passionate about precipitation and cross-flow filtration as size-selective separation techniques, I am dedicated to advancing such non-chromatographic purification strategies. Further, my expertise in UV/Vis and Raman spectroscopy for real-time monitoring enables deeper insights into the dynamics of such purification processes.

• Advances in Recovery and Purification - Part 2

Dr. Elena Dominguez Vega received her Ph.D. degree on analytical chemistry in 2011 at the University of Alcala (Spain). After joining the Biomolecular Analysis group at Utrecht University (The Netherlands) in 2012, she worked on the development of new electrophoretic methods for the analysis of biopharmaceuticals. In 2013 she continued as postdoctoral researcher at VU University where she focused on the study of protein heterogeneity, conformation and affinity. In May of 2017, Dr. Dominguez Vega joined the Center for Proteomic and Metabolomics at the LUMC as assistant professor were she continue her work on the characterization of glycoproteins of clinical and pharmaceutical interest. Furthermore she has expanded her research focus to the development of innovative analytical platforms for the analysis of gene therapy products. Over the years, Dr. Elena Dominguez Vega has closely collaborated with several pharmaceutical companies and has received multiple grants and awards in support to her research.

• Accelerating Analytical Development
• Process Modelling and Developability

Zorica leads Cell Line Screening and Development Unit at Novartis NIBR Biologics Center, responsible for development, engineering and characterization of various cell lines for research discovery purposes, and biologics manufacturing cell lines from early development and pre-clinical, up to commercial. During 17 years at Novartis, Zorica assumed different roles at the R&D interface – within early technical development and research as line function and project management. leading CMC teams, and cell line development unit.

• Cell Culture and Cell Line Engineering - Part 1

Leading Novasign as CEO, Mark is passionate to improve bioprocesses for the production of biopharmaceuticals, enzymes and substitutes for animal-derived proteins. With his team, he is developing a hybrid modeling software for both up and downstream processes. This software utilizes artificial intelligence applied to process data and first principle models (hybrid models) to not only accelerate bioprocess optimization but also to reuse these models for model predictive control strategies. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.

• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 2
• Cell Culture and Cell Line Engineering - Part 1

Michel received his MSc. in Biology/Chemistry in 1993 from the University of Utrecht and his PhD in 1999 from the Wageningen University and Research at the Laboratory of Biochemistry with background in structure/function relationships of proteins. Michel Eppink has more than 35 years of experience in Downstream Processing of large biomolecules (proteins, lipids, carbohydrates).From 2009 up to 2014 Michel Eppink was Associate Professor and from 2014 - 2024 he was Special Professor at the Department of Bioprocess Engineering at Wageningen University and Research heading a group of PhD candidates in the research of biorefinery technologies such as new purification/analytical techniques for proteins/lipids/carbohydrates. Since 2024 is he Professor at TU Delft at the Biotechnology Department in the field of Industrial Biopharmaceutical Downstream Processing. Furthermore, Michel was section member of the Downstream Processing section of the Dutch Biotechnology Association from 2009 - 2024 and since 2014 scientific committee member of the ISPPP.

• Advances in Recovery and Purification - Part 1

Daniel is a recent Ph.D. graduate from the division of chemical engineering at Lund University. Raised in the Swedish city of Örebro, he has lived in Lund for over 10 years after beginning his studies as a chemical engineer back in 2014. His research regards the development of digitalization tools for biopharmaceutical downstream processes, which includes digital twins, automation and control. In his off time, he is an enthusiastic home cook and is currently fascinated by Mexican and Japanese cuisine.

• Advances in Recovery and Purification - Part 2

David Estapé is a seasoned biotechnology expert with a Ph.D. in Chemical Engineering and 25 years of experience in facility design and GMP consulting across the biotech, vaccine, blood plasma, and ATMPs sectors. Having contributed to major biotech projects worldwide, from start-ups to leading pharmaceutical firms, David has a deep interest in emerging technologies and regulatory trends. He actively engages with organizations such as BioPhorum and the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves as the Technology Manager at CRB’s Basel office in Switzerland.

• AI and Process Control
• Gene Therapy Manufacturing

Andrew has 35 years’ experience within the biotech industry covering a broad range of applications. Most recently has been extensively involved in building and leading development, manufacturing, operational excellence and technology innovation teams. Recognised as a technology innovation leader has been involved in many collaborations, testing and implementations of a number of next generation solutions involved in process intensification, PAT and digital technologies. Now works as an independent consultant using extensive experience in next Gen technology and process intensification to help companies improve their processes by building a road map, strategy and implementation plan utilising the latest process technologies.

• Advances in Recovery and Purification - Part 1

Katerina Farukshina, a dedicated researcher in biotechnology, excelled as a downstream process engineer at Chugai Pharmaceutical in Japan, contributing significantly to the development of downstream processes for mAb drug substance production for crucial clinical studies. Transitioning to Cell and Gene Therapy Catapult in the UK, she assumed the role of associate lead scientist, where she continues to innovate within the viral vector technology space as part of the Process and Innovation team.

• Gene Therapy CMC and Analytics

I am a Senior Scientist, at iBET in the Cell Line Development and Molecular Virology Lab. My research focuses on viral vector production for gene therapy, particularly optimizing adeno-associated virus (AAV) production platforms in mammalian and insect cells. To achieve this, I have been using molecular biology and applied virology tools to engineer cell lines and virus. I am also studying the intricate connections between AAVs and their helper virus and involved in the implementation of analytical methods to assess vector productivity, purity, and biological activity. My goal is to provide healthcare solutions that can improve people’s lives, and I have been actively engaged in international industrial projects, translating academic research into technological advances and market value.

• Gene Therapy Manufacturing

Lara Fernandez Cerezo graduated from University College London with a Master of Engineering in Biochemical Engineering in 2014. She then pursued an Engineering Doctoral degree, a 4-year industrial PhD program with Merck focusing on scale-down filtration technologies of high concentration mAbs. Upon graduation, she established the ambr crossflow high throughput system as a process characterization/development UF/DF tool in the Merck process development teams. In 2019 she transitioned to continuous manufacturing (CM) in biologics gaining ‘hands-on’ experience in both non-GMP 50L development scale and GMP 500L clinical scale. Since moving back to the development group in the US in 2021, Lara continues to influence the GMP continuous manufacturing teams at Merck by providing recommendations for the design of our next-generation commercial CM facility including a customized SPTFF/ILDF Skid. Lara now spearheads novel downstream biologics continuous manufacturing projects in the Enabling Technology group at Merck. One of them will be PKM, which is the focus of today's talk.

• Intensified and Continuous Processing

Gisela Ferreira received her Ph.D. in Chemical Engineering from the University of Maryland Baltimore County in 2001 and is currently a Director in the Purification Process Sciences at AstraZeneca. Dr. Ferreira has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification (early and late stage development), Quality by Design concepts, scale-up, technology transfer, CMC project management, virus clearance, and regulatory agency interaction through commercial launch, including Imfinzi, Fasenra and Imjudo.

• Advances in Recovery and Purification - Part 1

Haiko Fischer joined Asahi Kasei Bioprocess in December 2017. He has been a member of the R & D team for three years and is now the Product Manager for Germany, Austria, Switzerland, and Eastern Europe. Haiko studied Chemical and Process Engineering, and as Product Manager, he assists his customers with all technical questions regarding Planova Virus Filters and BioOptimal Microfilters, as well as providing training on the respective products and technologies.

• Advances in Recovery and Purification - Part 1

Bastian Franke works at Numab Therapeutics AG as a group leader USP/DSP and leads a team of research associates responsible for the manufacturing of multispecific antibody-based therapeutics, process development and technical transfer to C(D)MOs, as well as implementation of automated and novel purification workflows. Prior to Numab he gained first industry experience at DSM as a scientist in downstream processing after a postdoctoral fellowship at the University of Basel, Switzerland, where he developed novel isotopic labelling techniques for NMR applications and automated multicolumn purification schemes in collaboration with Cytiva. Bastian Franke received his PhD in structural biology from the University of Queensland, Australia.

• Advances in Recovery and Purification - Part 1

Jonathan Garlipp obtained his Master’s degree in Process Engineering from ETH Zürich. Currently he is a PhD candidate in the Arosio Lab in the Institute for Chemical and Bioengineering at the Department of Chemistry and Applied Biosciences at ETH Zurich. His research interests focus on the development of innovative technologies based on phase separation for the scale up of downstream processes for biogenic nanoparticles, including extracellular vesicles.

• Advances in Recovery and Purification - Part 2

I am a recent PhD graduate in the Chemical Engineering department of Polytechnique Montreal, where I have also completed a Bachelor's degree. I have worked extensively on the Surface Plasmon Resonance (SPR) technique, more precisely on its current and potential applications in monitoring bioprocesses. This includes the elaboration of innovative assays and novel data analysis methods.

• Next-Generation Analytical Methods

MSc (1993) and PhD (1997) from Ghent University (Belgium). Postdoc positions (1998-2005) at Ghent University (Belgium), École Polytechnique de Montréal (QC, Canada), the Technical University of Denmark (DTU) (Denmark) and Lund University (Sweden). First associate professor at DTU Chemical Engineering (2005-2012), then Professor in Industrial Fermentation Technology ("The Novozymes professor") since 2013. Head of the Process and Systems Engineering Center (PROSYS) since 2014. CEO of Bioscavenge ApS, a startup with focus on resource recovery from bio-based production systems, from 2017 to 2021. Current research with focus on large-scale fermentation, mathematical modelling, investigation of mass transfer issues across scales, Process Analytical Technology (PAT), continuous production, resource recovery, process simulation with applications to fermentation, pharma, wastewater treatment and resource recovery operations.

• Cell Culture and Cell Line Engineering - Part 1

Lukas Gerstweiler is a lecturer in Bioprocess engineering at the School of Chemical Engineering at the University of Adelaide, Australia. He is currently establishing the biomanufacturing research group focusing on efficient manufacturing of biopharmaceuticals such as Virus-like particles, mRNA and recombinant proteins. The research focus is on continuous multi column chromatography, process modeling, process integration and better purification pathways.

• Intensified and Continuous Processing

No bio available.

• Cell Therapy CMC and Manufacturing

Dr. Christoph Gstöttner obtained his PhD in 2021 at the Leiden University Medical Center (Netherlands) under the supervision of Prof. M. Wuhrer. His PhD research was focused on the development of electrophoretic but also chromatographic methodologies for the in-depth characterization of biopharmaceuticals such as monoclonal antibodies or newer antibody formats. In his postdoc, he focuses on the development of new CESI-MS methods for the functional characterization of biopharmaceuticals and their affinity to Fc receptors.

• Gene Therapy CMC and Analytics

No bio available.

• AI and Process Control
• Gene Therapy Manufacturing

I am a bioprocessing expert with a background in pharmacy and a Ph.D. in Biochemistry. I have worked on Yellow Fever vaccine production developing upstream methods for Yellow Fever vaccine production using mammalian cells in microcarriers—a significant shift from traditional techniques. During my PhD, I focused on process development of recombinant blood proteins. Post academia, I transitioned into cell and gene therapy space. Initially, working on process development in various iPSC programs and most recently viral vectors. I currently work on USP & DSP optimisation and scale up for AAV production alongside managing technology transfers for clinical programs.

• Gene Therapy CMC and Analytics

Jahid is a Lead Scientist with 10 years of experience at the Cell and Gene Therapy Catapult. He has extensive experience developing processes across cell and gene therapy and leads the development of automated differentiation processes on the Allogeneic Cell Therapies programme. Jahid specialises in bioprocess translation with a strong focus on process automation and scale-up. His background is in Biochemical Engineering and he has a PhD in Tissue Engineering from the University of Leeds which focused on the decellularisation of porcine bone-meniscus-bone for use as a meniscal replacement.

• Cell Therapy CMC and Manufacturing

Benedikt holds a Master's degree in Biotechnology from the University of Natural Resources and Life Sciences, Vienna, with a specialization in Bioprocess Engineering. At Novasign, he is actively engaged in customer projects while pursuing a PhD. His research centers on developing an end-to-end model for continuous bioprocessing, encompassing various unit operations.

• Intensified and Continuous Processing

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Körber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

• Cell Culture and Cell Line Engineering - Part 1

Oliver Hesse is the Lead of CMC Digital Transformation and Data Science Capability Cluster at Bayer Pharma Product Supply, based in Berkeley, CA. He began his career in small biotech, developing high-throughput screening systems for large molecules that utilized automated decision-making. Since joining Bayer in 2008 and moving to the Berkeley site in 2011, Oliver has focused on lab automation, lab informatics, and data sciences. In his current role, which he assumed on August 1, 2024, he oversees the application of data science and digital technologies in both biologics and small molecules, enhancing process understanding and ensuring seamless integration from process development to commercial manufacturing.

• AI and Process Control
• Advances in Recovery and Purification - Part 2

PhD candidate at Karlsruhe Institute of Technology (MAB), working on digitization of processes and development PAT and data-driven sensor application in biopharmaceutical industry.

• Advances in Recovery and Purification - Part 2

Rick Hibbert obtained his Wellcome Trust PhD from Oxford University investigating IgE antibody biology. He subsequently worked as a Post-doctoral Research Fellow at the Netherlands Cancer Institute, later combined with a funded MBA. He joined Genmab in 2013 and is currently Senior Director and Head of the CMC Science and Technologies Department in Utrecht, focused on early and late-stage CMC development of Genmab’s antibody products.

• Advances in Recovery and Purification - Part 1

Margit Holzer is a biochemical engineer with extensive expertise in the development and implementation of biochemical/technological production processes. She holds a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer Ingelheim and Novasep, she held various positions in R&D, production and manufacturing, quality, and technology, including several executive positions such as Technology Director. Amongst other achievements, she has led a successful FDA inspection on a pharma and biopharma production site as Quality Director. She has been involved in the process development of more than 50 different biopharmaceuticals of different origins (recombinant and non-recombinant cell cultures, yeasts, microorganisms, viruses, plants, and fluids from vertebras). Currently, she works as Scientific Director at Ulysse Consult.

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• Intensified and Continuous Processing
• AI and Process Control
• Cell Therapy CMC and Manufacturing
• Advances in Recovery and Purification - Part 2
• Advances in Recovery and Purification - Part 1
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 2
• Cell Culture and Cell Line Engineering - Part 1

Christian is Senior Director, CMC Development Proteins, ADCs & Chemical Entities at BioNTech SE. Christian holds a PhD in Biology from the University of Mainz, Germany. He has 25 years of experience in biotech and pharmaceutical industry with a broad technical expertise ranging from early target and biomarker discovery up to late-stage CMC development and commercial manufacturing of protein-based biologics. Prior to joining BioNTech, Christian worked in various positions at Rentschler Biopharma SE, Merck KGaA, and ProteoSys AG.

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• Intensified and Continuous Processing
• AI and Process Control
• Cell Therapy CMC and Manufacturing
• Advances in Recovery and Purification - Part 2
• Advances in Recovery and Purification - Part 1
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 2
• Cell Culture and Cell Line Engineering - Part 1

Madelène holds a Master of Science in Engineering in Biotechnology from Lund University in Sweden. She is currently a PhD student at the Department for Process and Life Science Engineering at the same university. Her research focuses on developing more efficient, robust and sustainable downstream processes for purification of biopharmaceuticals, through integrated continuous processing, increased automation and improved buffer management.

• Advances in Recovery and Purification - Part 2

Inês Isidro is Head of the Biosystems and Data Science Group at iBET. She holds a PhD in Bioengineering and her current research combines machine learning, mechanistic modeling, systems biology, and other advanced data analytics platforms to design tailored data-driven strategies to address three major challenges: improving bioprocesses for cell and gene therapy, enabling precision medicine, and supporting drug discovery.

• AI and Process Control
• Cell Culture and Cell Line Engineering - Part 2

Kalle is a bioprocessing industry veteran who has led the development of robust, scaleable cell culture media and processes. He earned a BS in biology from Utah State University and an MS in biotechnology from Johns Hopkins University. During his tenure at HyClone (ThermoFisher and GE Healthcare), he developed many new standard and custom media. Currently, he is Sr. Director of Cell Culture Media at UPSIDE Foods, a cross-functional effort across R&D, raw materials, supply chain, and production operations. Under his leadership, UPSIDE has established serum-free and animal component-free media platforms designed to support multiple species and cell type.

• Cell Culture and Cell Line Engineering - Part 2

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

• Advances in Recovery and Purification - Part 1

Stefan Junne's aim is to develop and optimize bioprocesses in mono-, co- and mixed cultivations, considering single-cell physiological and population-related aspects. This includes the use of taylor-made bioreactor design and process analytical technology to investigate and understand the interactions between cells and bioreactors and implications for process design and control. The impact of population heterogeneities on process performance and how these effects can be reduced is another important aspect of his research. His activities also include research on single-use bioprocessing: single-use bioreactors offer a unique design versatility on a commercial scale, are interesting for their combination in upstream bioproduction to optimize cell viability. The study of single-use bioprocessing under the consideration of sustainability aspects is important to develop tools to decide for a certain combination of single-use and stainless steel equipment. Stefan is currently associate professor of bioprocess engineering at Aalborg University, Denmark. Previously, he was a group leader at TU Berlin. He also completed his PhD in bioprocess engineering there in 2010, after having graduated as a chemical engineer in 2003.

• Cell Culture and Cell Line Engineering - Part 1

Oliver Kaltenbrunner is a Scientific Director of Amgen Process Development and has extensive experience leading the advancement of clinical and commercial processes through their development cycle. Roles have focused on commercial and clinical process support, process optimisation, process economics, multi-site engineering strategies, process transfer, and validation support. Currently, he leads a Manufacturing Technologies group, overseeing the introduction of new technologies into GMP manufacturing of therapeutic biologics.

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• Intensified and Continuous Processing
• AI and Process Control
• Cell Therapy CMC and Manufacturing
• Advances in Recovery and Purification - Part 2
• Advances in Recovery and Purification - Part 1
• Gene Therapy Manufacturing
• Gene Therapy CMC and Analytics
• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 2
• Cell Culture and Cell Line Engineering - Part 1

Tony Bou Kheir leads the analytical development and Quality Control programme at Purespring Therapeutics; developing new analytics to support product characterisation and release. Tony has over 10 years’ experience in the design, development, and application of novel analytics to support product characterisation. Tony leads a team focused on improving AAV manufacture through the design and application of new technologies for in-process testing, and the development of more accurate and robust assays for product release. Tony’s team also oversees assay qualification and technology transfer to 3rd party GMP facilities and CDMO’s.

• Gene Therapy CMC and Analytics

Takanori Kigawa, Dr. Sci., is Senior Scientist of RIKEN Center for Biosystems Dynamics Research (BDR), Japan. He graduated from Graduate School of Science, the University of Tokyo in 1994 and started his professional career as a research scientist in RIKEN. He has developed a variety of technologies related to the cell-free protein synthesis system and NMR-based structure biology, and most of them were patented and commercialized.

• Cell Culture and Cell Line Engineering - Part 2

Dr. Bettina Knapp has been a part of Boehringer Ingelheim's biopharmaceutical division since 2015. Initially, her responsibilities encompassed various areas, including the validation of Stage 3 drug substances and drug products where she also served as a representative during authority and customer inspections in the realm of Boehringer’s biopharmaceutical contract manufacturing. In the past five years, her focus has shifted towards biopharmaceutical development, with a particular emphasis on upstream development. However, her expertise also extends to downstream and analytical development. As of 2022, Dr. Knapp has assumed the role of Laboratory Head in Late Stage Upstream Development. In this capacity, she is, among other responsibilities, actively promoting the integration of models and digital twins into bioprocess development. Furthermore, Dr. Knapp has recently taken on the additional role of Product Owner for the Scrum Team "Biobase." This team is responsible for an internally developed software that integrates Biological Development and Manufacturing data. This software facilitates rapid, data and model driven decision making and fosters digital innovation across the entire development process.

• AI and Process Control
• Cell Culture and Cell Line Engineering - Part 2

Dan Bach Kristensen holds a Ph.D. in biology and B.Sc. degree in chemistry. Dan is specialized in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research in Japan and later in Denmark. For the last 20 years Dan has been working with analytical characterization in the biopharmaceutical industry, on projects ranging from early discovery through to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases and oncology. Dan currently works as a Scientific Director at Symphogen, which is specialized in the development of antibody-derived formats, including antibody-drug conjugates and bispecific antibodies, for the treatment of cancer and other indications.

• Next-Generation Analytical Methods

PhD in Dresden in the field of molecular virology - development of novel transient retroviral (foamyviral) vectors (2015-2019) University collaboration with GSK developing cell lines for lentiviral vector manufacturing (2020-2021) Leading lentiviral cell line development at Novartis (2021-today)

• Gene Therapy Manufacturing

Sharon Longhurst is the founder and Director of Advanced Biologics Consulting (ABC) Ltd. She has more than 20 years experience in product development, encompassing viral vectors, cell therapy and recombinant protein products. Prior to establishing ABC, Sharon was VP Development at GADETA BV, and has held senior roles in industry, including Immunicum AB (now Mendus) and Akari Therapeutics. Sharon was a Senior Quality Assessor at the MHRA for 6 years and worked closely with the EMA at that time, primarily within the Biologics Working Party and Gene Therapy Working Party.

• Cell Therapy CMC and Manufacturing

Jørgen Magnus, with a Master's in Chemical Engineering and a PhD in Biochemical Engineering, has extensive experience in pharmaceutical production. He previously worked at NNE Pharmaplan and Bayer AG, focusing on biotechnology and process development. In 2023, he became head of Bioprocess Engineering at RWTH Aachen University, where his research centers on bioreactor process characterization for industrial and pharmaceutical biotechnology applications.

• AI and Process Control
• Cell Culture and Cell Line Engineering - Part 2

Juergen is the co-founder of enGenes Biotech, leveraging his deep expertise in genetic and bioprocess engineering, as well as continuous bioproduction and plasmid DNA production. He previously worked as a Research Associate at the University of Natural Resources and Life Sciences (BOKU), Vienna, Austria. Before founding enGenes Biotech, Juergen held a Postdoctoral position at the Austrian Centre of Industrial Biotechnology (ACIB GmbH), where he contributed to the 'Microbial Cell Design' research initiative, focusing on sequencing and engineering various host strains for the production of recombinant proteins. In addition to his work on continuous bioproduction processes and plasmid DNA production, Juergen has authored numerous peer-reviewed scientific publications and book chapters. He has also received advanced training in Systems Biology and genome-scale stoichiometric modeling from the University of Iceland and in Microbial Genomics and Transcriptomics from the University of Bielefeld. He holds a PhD in Biotechnology from the University of Natural Resources and Life Sciences, Vienna, Austria.

• Intensified and Continuous Processing

Damian Marshall is the Vice President of Analytical Development at Resolution Therapeutics, a UK biopharmaceutical company developing engineered macrophage therapies for end-stage liver disease. Prior to joining Resolution, Damian spent 2 years as Vice President of Bioprocess Development at Achilles Therapeutics and 8 years as Director of New Technologies at the Cell and Gene Therapy Catapult. In these roles he led multi-national programs working on bioprocess automation, PAT integration, and advanced product characterisation.

• Cell Therapy CMC and Manufacturing

Dr. McCarthy is Senior Director, Science and Standards in USP’s Global Biologics Department, where she leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports standards and tools across a diverse range of therapies, including vaccines, peptides, cell and gene therapy, monoclonal antibodies, and other protein therapeutics. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

• Next-Generation Analytical Methods

Angeles Mecate Zambrano, Ph.D., is a senior scientist in our Process Solutions, Liquid Formulation R&D team, specializing in formulation development of novel modalities. With a profound passion for medical virology, she has dedicated her academic and professional journey to deepening her understanding and conducting research in this field. In 2022, Dr. Mecate Zambrano joined Merck, bringing her knowledge and insights in virology to the table. Her primary objective is to leverage this expertise in creating innovative formulation solutions utilized for viral vector manufacturing.

• Next-Generation Analytical Methods

No bio available.

• Gene Therapy Manufacturing

Dr. Miller is an accomplished biopharmaceutical executive with over 25 years of industry experience, leading multiple CMC functions in the development and commercialization of advanced therapeutics, including cell and gene therapies, inhalation and parenteral formulations, multi-active solid oral dosage forms, and device/combination products. Believing strongly in the criticality of robust product characterization for the success of the regenerative medicine industry, she specializes in method development, validation and transfer, as well as quality control testing and specification strategies, comparability studies, and analytical capability build vs. buy analysis at Dark Horse Consulting.

• Cell Therapy CMC and Manufacturing

Sara has spent 12+ years working with biotech companies and academic labs focusing on applications of human primary cell cultures and autologous and allogeneic cell therapy products for therapeutic applications. She joined Dark Horse Consulting in 2016 bringing her expertise in aseptic and cGMP manufacturing process development, risk analysis, CMC and regulatory filings, facility design and project management to advise growing cell and gene therapy companies. Sara’s range also encompasses experience in managing cross-regional technology transfer, Design of Experiments, establishment of supply chain, ancillary material risk assessment and leading root cause analysis for gene therapies and autologous (CAR-T, immuno-derived and iPSC) and allogeneic cell therapies. During her time at DHC she has been fortunate enough to work with over 70 clients on over 80 different products and originate from at least 9 different countries.

• Cell Therapy CMC and Manufacturing

Ali Mohamed, Ph.D., Vice President, CMC, Immatics US Inc. was formerly the Senior Director of Manufacturing Operations/Manufacturing Development at PCT (now HCATS). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical-stage companies, including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a Ph.D. in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in Neuroscience and Neurobiology from Georgetown University.

• Cell Therapy CMC and Manufacturing

Yogapriya works as a Scientist I at Biogen, Inc. in the Drug product group of Biologics and Advanced therapy medicinal products department. She has over 10 years of experience in Research and Product Development of Biologics comprising of monoclonal antibodies and AAV drug products. She has managed multiple biologics programs at different stages of development. Her current role focuses more on the developability assessment of biologics (mAbs and AAV) to help in candidate selection process for R2D transitions and end-to-end drug product development of biologics drug product candidates from R2D to FIH with respect to formulation lockdown, process development, and container closure selection. In the past, she has worked as a biochemist in discovery programs focused on purification, biochemical, and biophysical characterization of monoclonal antibody therapeutics.

• Accelerating Analytical Development
• Process Modelling and Developability

Milla Neffling, PhD., is a market segment manager for bioprocessing at 908 Devices. Milla works with bioprocess labs and scientists in the fields of biotherapeutic proteins, viral vectors, vaccines and cell therapies, to apply analytical solutions to drive bioproduction and its development. She earned her doctorate in Finland, at Åbo Akademi University in the field of analytical biochemistry.

• Cell Culture and Cell Line Engineering - Part 1

Professor Neubauer is head of the Bioprocess Engineering Laboratory at TU Berlin which is leading in bioprocess scale-up and automated bioprocess development. He leads the KIWI-biolab which was selected as an International Future Laboratory in AI for bioprocess development. He is co-author in more than 300 publications and 20 patents and cofounder of the companies BioNukleo, Enpresso, and Cell-tainer. In 2023 he obtained the prestigious Thought Leader Award from Agilent.

• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 1

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. At the same time Christiane was a biologicals Senior Quality Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). As UK CAT Rapporteur she was responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline, and a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to get cell and gene therapies into the clinic and to market. Since joining Parexel, Christiane has done a significant amount of work within the US regulatory system and can advise on EU, UK and US CMC considerations.

• Cell Therapy CMC and Manufacturing

No bio available.

• Gene Therapy Manufacturing

Associate Director leading a team within the JJIM Gene Therapy R&D organization. Specializing in Drug Substance Tech Transfer/NPI, process validation, and manufacturing interface and CMC support for a portfolio of AAV gene therapy. PhD in Oncology Immunotherapy and a bachelor’s degree in Pharmaceutical Sciences. Alumni of the Johnson & Johnson Global Operations Leadership Development Program (GOLD).

• Gene Therapy CMC and Analytics

I am a research scientist who is deeply fascinated by the behaviour of proteins in cells, in living systems and in recombinant engineered systems. The junction of biology, chemistry and physics is of particular interest to me and is manifest in my many collaborative relationships in Europe and the US. I am also a Science Foundation Ireland funded investigator with BEACON, the Bioeconomy Research Centre, that enables me to use my expertise in protein engineering to drive creation of value in the circular economy, ensuring that excellent science creates products and technologies with sustainable properties, and to further enhance the reputation of UCD as Ireland’s number one university.

• Advances in Recovery and Purification - Part 1

Michael Olma is a biochemist by training with PhD from the ETH Zurich. After switching from academia to industry, he developed bioanalytical assays for small and large molecules at a global CRO. In 2016, he joined MSD to introduce Mass Spectrometry for GMP at the site. Since 2020, he also leads the GMP Advanced Analytics lab, which focuses mainly on establishing, using and advancing Biologics PAT tools in regulated environments.

• Intensified and Continuous Processing

After completing his dual Bachelor's and Master's degree at the Anhalt University of Applied Sciences in Köthen, Germany, Jan Ott started as a PhD student and research assistant in the Cell Cultivation and Bioprocess Engineering group at the ZHAW Zurich University of Applied Sciences in 2019. In 2024, he completed his dissertation on "Upstream Process Intensification Using an Ultra-High Cell Density Chinese Hamster Ovary Cell Bank" in cooperation with the TU Berlin. He continues to work as a research associate at the ZHAW, mainly in teaching and in research and development, focusing on mammalian cells.

• Cell Culture and Cell Line Engineering - Part 1

No bio available.

• AI and Process Control
• Advances in Recovery and Purification - Part 2

Diego Oyarzún is a Reader in Computational Biology at the University of Edinburgh. He leads a research team at the interface of biology and computation, with a focus on AI-powered discovery and decision support systems for biomedicine and biotechnology. Diego is Fellow of the Royal Society of Biology and the Alan Turing Institute, the UK's national institute for AI and data science. He has received awards from the World Economic Forum and the G20 for his work at the interface of data science and biotechnology. His work relies on techniques drawn from control theory, optimisation, network science, and machine learning, to understand the structure and function of biological processes, with applications in synthetic biology, drug discovery, and fundamental science.

• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 1

Zach Pang is Group Leader at the Bioprocessing Technology Institute, A*STAR and Senior Scientist at the Bioinformatics Institute, A*STAR, where he leads a research team to drive digitalisation in biomanufacturing. His research interests include mechanistic modelling and process modelling of bioprocesses. He is also Assistant Professor (adj) at NUS Department of Biomedical Engineering and NTU School of Chemistry, Chemical Engineering, and Biotechnology. He developed an interest in cross-disciplinary research when he was pursuing his Bachelor of Technology in Mechanical Engineering at the National University of Singapore, where he did his undergraduate research on cancer cell mechanics. He subsequently joined the Department of Bioengineering at Imperial College London to pursue his PhD under the A*STAR Scholarship. Zach Pang also holds a Master of Business Administration from Quantic School of Business and Technology and a postgraduate certificate in learning and teaching in higher education from the University of London. He is a chartered engineer (CEng) with the Engineering Council UK, an associate fellow of the Higher Education Academy, UK (AFHEA) and a member of the Institute of Physics and Engineering in Medicine (MIPEM).

• AI and Process Control
• Cell Culture and Cell Line Engineering - Part 2

I am biologist by degree with a background in immunology and cancer immunotherapy. I graduated in 2016 with a Master's degree in Applied Genetics and have been working as a process development scientist since. I have worked closely with CMC professionals to plan and perform experiments to provide data for regulatory submissions as well as authoring and reviewing IND/IMPD sections. My scientific interest lies in the development of more robust, closed and automated processes that can deliver life saving treatments to patients.

• Cell Therapy CMC and Manufacturing

Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology) New University of Lisbon and she holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biológica (ITQB) from New University of Lisbon. Working in Animal Cell Technology field since 1996, her PhD contributed to the establishment of several scalable purification processes for complex biopharmaceuticals, mainly virus and virus like particles for vaccine and gene therapy. Cristina coordinated several research contract projects with Industrial partners, some of the processes developed are nowadays in GMP for phase I and II and she published over 60 manuscripts in refereed international journals.

• Advances in Recovery and Purification - Part 2

Patricia Pereira Aguilar is a Senior Scientist at the Austrian Centre of Industrial Biotechnology (acib, GmbH) and integrated in the Institute of Bioprocess Science and Engineering (IBSE) at the BOKU University, Vienna, Austria. In 2020, she completed her Ph.D. degree in “Biomolecular Technology of Proteins” (BioTop) at BOKU, under the supervision of Professor Alois Jungbauer. After that she started working as a Postdoctoral Researcher at acib and since January 2024 as a Senior Scientist and Research Group Lead. Her research focus on the development of downstream processes and analytical tools for enveloped bionanoparticles for vaccine and gene therapy applications, such as virus-like particles, viruses and extracellular vesicles. Her expertise includes chromatography, filtration and ultracentrifugation techniques and biochemical and biophysical assays for bionanoparticle/protein/nucleic acid quantification and characterization. Within her work as Scientist/Senior Scientist, she has contributed to grant/project writing, application and acquisition, project lead, publication writing and reviewing, participation in international conferences, and supervision and guidance of PhD/Master students and technicians.

• Advances in Recovery and Purification - Part 2

Curtis Phippen acquired his PhD from Southampton University in 2015, with a focus on the purification and crystallization of Pseudomonas proteins. In 2016 he joined the downstream team at UCB where he performed late-stage process characterisation work on a range of E. coli and mammalian-based antibody formats. During this time he also worked on several different innovation projects to streamline the clarification and capture steps of mammalian processes. This led to the development of a robust Protein A Expanded Bed Adsorption (EBA) method that can purify antibodies directly from cell culture. In 2023 he joined the early-stage team at UCB and is now helping to develop new processes.

• Advances in Recovery and Purification - Part 1

Jamie Piret is a Professor at the University of British Columbia in the Department of Chemical & Biological Engineering and the School of Biomedical Engineering. He has a Bachelor’s from Harvard in Applied Mathematics to Biochemistry and a Chemical Engineering doctorate from MIT. At UBC his research focuses on innovative process and device technology for therapeutics biomanufacturing. His recognitions include the 2012 Cell Culture Engineering Award and the 2022 Meggers Award, from the Society for Applied Spectroscopy.

• Accelerating Analytical Development
• Process Modelling and Developability

Maria del Carme Pons Royo is a bioprocess engineer with experience in development and optimization of biotechnological products. She completed her bachelor's degree in biotechnology from Universitat Autonoma de Barcelona, followed by a master's degree in Life Science and Technology from TU Delft. Recently, she successfully defended her PhD thesis at BOKU, titled "Millifluidic devices to accelerate process development with a primary focus on protein precipitation and filtration." Currently, she is employed as a postdoctoral researcher at MIT, where she continues her research on the development and optimization of innovative bioprocesses utilizing cutting-edge prototyping tools.

• Intensified and Continuous Processing

After studying at ENS Cachan (now Paris-Saclay), Arnaud Poterszman completed his PhD from Strasbourg University and joint the CNRS one year later. He holds a Research Director position and performs his studies in the Department of Integrated Structural Biology at IGBMC, Illkirch France. He has a dual expertise in Structural and Molecular biology with insights on expression technologies and sample preparation. His research is focused on eukaryotic multi-protein complexes involved in transcription regulation and DNA repair by nucleotide excision, particularly, the transcription/DNA repair factor TFIIH and its partners (Orchid 0000-0002-6702-5777)

• Cell Culture and Cell Line Engineering - Part 2

Philip is an experienced research scientist familiar with high-throughput process development, design of experiment approaches to process optimisation and process scale up and validation. At CPI Biologics, Philip manages the technical team, working across mammalian, microbial, viral and cell-free projects.

• Cell Culture and Cell Line Engineering - Part 1

Pranav Puri, PhD, Head Process Development, is leading process development and scale up activities at VectorY to ensure availability of robust and well-yielding platform technologies for AAV production and thereby enabling the progress of VectorY’s candidate novel therapeutics (AAV-based vectorized antibodies) from early R&D to clinic.

• Gene Therapy Manufacturing

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• Intensified and Continuous Processing

Veronika Reisinger works currently in the physico-chemical characterization group at Novartis Global Drug Development in Austria as laboratory head. Before joining Sandoz in 2011 as scientist, Veronika worked as a postdoctoral fellow in a protein biochemistry laboratory at the University of Stavanger, Norway. Her current work focuses on the mass spectrometric characterization of biopharmaceuticals and associated impurities.

• Next-Generation Analytical Methods

Kathleen has more than 40 years’ experience in the biologics industry. Kathleen has served as site head and general manager at Amgen, Genzyme, and Charles River, where she oversaw manufacturing, QA, QC, process development, and supply chain. The majority of her professional career was spent at Amgen. Over the course of her tenure at Amgen, Kathleen held a variety of positions of increasing responsibility, including VP / GM of Amgen’s Rhode Island Facility and Site Head of Amgen’s multi-plant Thousand Oaks manufacturing site. Over her career, Kathleen has been responsible for the successful manufacture of a number of top biologics including EPOGEN, Neupogen, Aranesp, Neulasta, Infergen, Enbrel, Cerazyme, Fabrazyme, and Myozyme. Kathleen holds an undergraduate degree from Brown University, and a master’s degree from Stanford University.

• Gene Therapy CMC and Analytics

Antonio Roldão is the Head of Vaccine Development Laboratory at the Animal Cell Technology Unit (Health & Pharma Division, iBET). Antonio Roldao graduated in Chemical Engineering at the Faculdade de Ciências e Tecnologia da Universidade Nova de Lisboa, and holds a PhD in Engineering and Technology Sciences, Systems Biology from ITQB-NOVA. Current research is driven by the aim to develop novel complex biologics with impact in human and animal Health, and directed to both developed and developing countries. The basis for his work lies on the use and integration of multidisciplinary technologies such as synthetic biology, evolutionary and bioprocess engineering, and bottom-up systems biology to fasten the generation of the products he’s interested in, particularly virus-like particles (VLPs)-based vaccines against infectious and/or neglected diseases (e.g., Influenza, Dengue or haemorrhagic fever). Over the next 5 years he wants to consolidate his research career and continue developing novel bioprocesses for production of vaccines against high-impact (economic- and human-wise) diseases, thus providing solutions to those who most need. CV Highlights: (i) Author of 20 scientific manuscripts in peer-reviewed journals and author/co-author of 3 book chapters (over 850 citations and h-index =13 - Scopus metrics); (ii) Over 20 poster and 15 oral communications (11 invited); (iii) Supervision of 7 PhD students and 1 Junior Researcher; (iv) Best PhD thesis of ITQB-NOVA in 2011; (v) “Investigador FCT 2014” from Fundação para a Ciência e a Tecnologia (Portugal); (vi) PI/co-PI of national and European public/private funded projects (Portuguese Science Foundation - 2, Swedish private foundations – 2); (vii) Project manager of Portuguese (1), Japanese (1), EU (7), pharma/biotech (2) funded projects; (viii) Member of organizing committee of two international scientific meetings and five courses on animal cell technology and protein production; (ix) Reviewer in international scientific journals.

• Intensified and Continuous Processing
• Gene Therapy Manufacturing

Cecilia Roque is an Associate Professor in Bioengineering at the Chemistry Department, School of Science & Technology at NOVA University (Lisbon, Portugal). Cecilia is a principal researcher at UCIBIO-NOVA and leads the Biomolecular Engineering Lab. She holds a degree in Chemical Engineering (Major in Biotechnology) & a PhD in Biotechnology from Instituto Superior Técnico, and has an Habilitation in Bioengineering from NOVA University of Lisbon. Cecilia has been a Visiting Scholar at the University of Cambridge and at the Catholic University of America, a Postdoctoral Researcher at the Institute of Biotechnology (University of Cambridge) and at INESC-MN (Lisbon, Portugal), and a visiting Professor at the University of Cambridge (2006, 2011), University of São Paulo (2015-2018), University of Nantes (2011) and City University of New York (2018). Her research focuses on bioengineering, namely on the development of advanced functional materials that combine novel affinity receptors with bio-based and sustainable materials for bioseparation, biosensing and biomedical applications. Check: https://sites.fct.unl.pt/biomolecular_eng/

• Advances in Recovery and Purification - Part 1

Peter is a bioengineer and entrepreneur, with PhD and postdoc training from Techn. Uni. of Denmark and Chalmers. Founder of Enduro and today serves as CSO, overseeing R&D and implementation projects.

• Cell Culture and Cell Line Engineering - Part 1

Florence holds a PhD in Molecular and Cellular Biology from Strasbourg University. She gained considerable experience in product development and regulatory affairs, bringing many of the early cell and gene therapies from the bench to the clinic in the early 2000s, and to approval such as Glybera (first gene therapy in the EU) in 2012. She supported the development of a number of AAV-based gene therapy vectors for various disease areas. From 2014 to 2021 she was Director Global Regulatory Affairs CMC Cell and Gene Therapies, where she worked on the global approval of Kymriah (first CAR T product), Luxturna and Zolgensma. She has worked as regulatory affairs and development expert for several start-ups and venture funds before joining Hookipa Pharma in 2023 to support the late stage development of their arenaviral vectors in various cancer indications.

• Cell Therapy CMC and Manufacturing

Sabrina is a seasoned expert in downstream bioprocessing with nearly 10 years of experience. She earned her PhD in Biophysics and Molecular Microbiology from the University of Groningen, the Netherlands, in 2019. Following her doctoral studies, Sabrina joined Purolite, where she specialized in resin development and purification optimization for novel monoclonal antibodies. In early 2021, Sabrina transitioned to Roche, joining the Gene and Cell Therapy department. Since then, she has been leading bioprocess development for plasmid production and purification, working on projects that range from small-scale parallel automated solutions to pilot-scale operations.

• Advances in Recovery and Purification - Part 2

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

• Intensified and Continuous Processing

Matthew has been working in the pluripotent stem cell field for over 15 years. He gained his undergraduate degree in Biochemistry from Imperial College London before going on to complete a PhD. at The Institute of Ophthalmology, University College London, under the tutelage of Professor Peter Coffey. His project aimed to develop novel cell therapies for the treatment of ophthalmic disorders by investigating the potential for transdifferentiation of human embryonic stem cell-derived retinal pigment epithelium (hESC-RPE) into neural retina, for transplantation into patients suffering from retinal degeneration. Following his PhD, Matthew undertook a post-doctorate position at University College London developing in vitro models of monogenetic eye disorders brought about by premature stop codons. The models were used to assess translational readthrough strategies to restore normal gene expression and ameliorate the disease pathology. Having maintained a keen interest in translation of promising cell therapies, Matthew subsequently joined the Cell & Gene Therapy Catapult in 2017 as a process development scientist in the Technology & Process Innovation (TPI) Team where he now leads the allogeneic cell therapy programme as a Lead Scientist. The Cell & Gene Therapy Catapult’s TPI team aims to develop next-generation manufacturing strategies for cell and gene therapy production, while helping to develop an environment that can best support developers as they move towards the clinic and beyond. Matthew has gained a broad appreciation of the cell & gene therapy landscape having lead, and delivered, projects involving: process & analytical development, novel technology development, cell engineering, non-viral gene delivery, immunotherapy, process diagnostics & CMC, data management strategy, technology transfer, amongst others. Matthew is one of the Cell & Gene Therapy Catapult’s resident experts in the emergent pluripotent stem cell therapy field, which comprises a large component of the allogeneic cell therapy programme.

• Cell Therapy CMC and Manufacturing

Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focuses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points. This development marks the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product (i.e. the solution under-going freeze-drying). This feature of the technology sets it apart from other in-process impedance measurement systems, in which a bulky electrode assembly is inserted into the solution being freeze-dried, to provide a product-non-invasive technology. His research on TVIS has focused on understanding the correlation between impedance measurements and the physical state of the material inside the vial, which has helped optimize lyophilization processes.

• AI and Process Control
• Advances in Recovery and Purification - Part 2

Sarah Snykers is Senior Director of Operations at Legend Biotech, Ghent Europe. She has 20 years of experience in cell and gene therapy (CGT). She has headed several departments in Biotech companies, including Manufacturing, QC, R&D and MS&T; all focused on clinical or commercial production of autologous & allogeneic cell- and gene therapeutic products. Over the last 15 years, she was involved in 3 greenfield production hubs, and in several global Tech Transfer projects for clinical/commercial production of CGT.

• Cell Therapy CMC and Manufacturing

Katarzyna Sobkowiak received her Master degree in Medical Biotechnology at Poznan University of Medical Sciences in 2011 and her PhD in Molecular Biology at University of Geneva in 2016. Katarzyna has a strong background in molecular biology and mammalian cell culture. In 2018, Katarzyna has moved to biopharmaceutical industry. She started as Cell Line Development Scientist at Merck Serono SA (affiliate of Merck KGaA, Darmstadt, Germany). Currently, she works as Scientist in Cell Line Technology Innovation group at Ares Trading SA (an affiliate of Merck KGaA, Darmstadt, Germany), where she is involved in evaluating new technologies and developing new protocols for improving and accelerating CLD workflow. Additionally, she has worked on developing protocols for stem cell culture and differentiation.

• Cell Culture and Cell Line Engineering - Part 2

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

• Next-Generation Analytical Methods
• AI and Process Control
• Process Modelling and Developability
• Cell Culture and Cell Line Engineering - Part 1

Mattia Sponchioni received his Master of Science in Chemical Engineering in 2015 with a grade of 110/110 cum laude and his PhD cum laude in Industrial Chemistry and Chemical Engineering in 2018, both at Politecnico di Milano. After his PhD, Mattia spent one year as a post-doc at ETH Zürich in 2019, working on the development of continuous countercurrent chromatographic processes for the purification of biopharmaceuticals, from therapeutic proteins to oligonucleotides. From 2020 to the present he is an assistant professor at the Department of Chemistry, Materials and Chemical Engineering “G. Natta” at Politecnico di Milano. Here, Mattia Sponchioni is leading the group of biomanufacturing, active in the development of continuous perfusion processes for the production of mRNA and bioplastics via fermentation and in the conversion of the traditional single-column batch chromatographic purifications into continuous countercurrent processes based on two twin columns. The vision of the group, inspired by the principles of Industry 4.0, is towards process intensification, to be achieved through both continuous processes and integrated manufacturing, as a way not only to increase productivity but also the sustainability of biomanufacturing, by reducing the wastes of buffers and feedstocks in the direction of a reduced environmental footprint.

• Advances in Recovery and Purification - Part 2

University Professor at the Department of Biotechnology (BOKU), Head of the Institute of Bioprocess Science and Engineering, Head of working group fermentation technology and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

• Intensified and Continuous Processing

Dr. Svilenov is currently an Associate Professor at the Technical University of Munich. His research interests are in the development, formulation and manufacturing aspects of biotherapeutics. Before joining TUM, Dr. Svilenov was Associate Professor at Ghent University. Previously, he was a postdoctoral researcher funded by a Peter and Traudl Engelhorn Fellowship and a grant from the Else Kröner-Fresenius Foundation in the group of Prof. Johannes Buchner at the Technical University of Munich. From 2016 to 2019, Dr. Svilenov did his PhD training supported by a Marie Sklodowska-Curie Fellowship under the supervision of Prof. Gerhard Winter at the Ludwig Maximilian University of Munich. He defended his doctoral thesis with the highest distinctions in Germany (summa cum laude) and received the AbbVie prize and the Carl-Wilhelm-Scheele of the German Pharmaceutical Society for his work. Dr. Svilenov is a pharmacist by training.

• Next-Generation Analytical Methods

Clare supports global teams of scientists, engineers and sustainability leaders to create tools to reduce the environmental impact of biomanufacturing. She has led the creation of an environmental impact maturity model for biomanufacturing, setting out the steps required to embed circularity and decarbonize across the product lifecycle. She is leading a team of engineers to target environmental hotspots in the biomanufacturing space, seeking to optimize HVAC through the creation of assessment tools and guidance documents for dynamic airflow control. She leads on BioPhorum's product carbon footprint calculation and reduction strategy.

• Intensified and Continuous Processing

I have worked in the development of innovative drug delivery systems and on the discovery of cancer stem cell biomarkers and advanced therapies (from small molecule drugs to antibodies and gene-therapies). Currently, I am working towards the biopharmaceutical development of gene therapy-based therapeutics within AstraZeneca, with a particular focus on RNA vaccines (mRNA and self-amplifying mRNA). My focus is on the development of analytical methods that enable comprehensive product understanding and provide adequate product quality control. I am also actively engaged in internal and external workgroups, focusing on topics related to the quality of RNA-based therapeutics for human use.

• Gene Therapy CMC and Analytics

Dr. Jens Traenkle is Head of PAT & Automation at Bayer. Together with his group he supports PAT activities for Bayer’s biopharma initiatives. The mission of the group is to bring lab analytics closer to the process and to integrate the resulting data. Dr. Traenkle has studied biochemistry and specialized on biophysics and protein structure during his PhD thesis at the Max-Planck-Institute for Molecular Physiology in Dortmund. He joined Bayer in 2006 and held previous positions in bioanalytics in Switzerland and in Germany within the company. Since 2012 he is responsible for PAT for Biotechnology at Bayer.

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• AI and Process Control

Molly Tregidgo is an upstream processing specialist with over 8 years of experience in biotechnology. She holds a doctorate of engineering from University College London, where she designed novel scale-down models for high cell density perfusion bioprocess development. Currently a Senior Bioprocess Scientist at CGT Catapult in the UK, her work focuses on the development and optimization of intensified processes for cell expansion and production for both gene delivery and allogeneic cell therapy processes.

• Gene Therapy Manufacturing

Dr. Uchiyama, PhD, is Professor in the department of Biotechnology, Graduate School of Engineering, Osaka University, Japan, and is also currently Visiting Professor at Kyoto University and ExCELLS, Japan. His research topics are science-based engineering in the field of solution biophysics of protein and colloidal particles, especially by using various kinds of biophysical methods, such as analytical ultracentrifugation, mass spectrometry (especially native MS and HDX-MS), and calorimetry. His research interests include energetic understanding of immune-related proteins and virus vectors for gene therapy. Container closure system for biopharmaceuticals with better quality and more safety is also in his recent scope. He has published more than 200 peer-reviewed papers, including those in high impact journals, such as Nature and PNAS, and is on the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. In addition, Dr. Uchiyama has received Young Investigator Awards from the Protein Society of Japan, and is a member of the organizing committee of the Protein Society of Japan and the project committee of the Japan Association of Animal Cell Technology.

• Gene Therapy CMC and Analytics

Dr. Shahid Uddin is currently Director of Drug Product, Formulation & Stability within the CMC department at Immunocore. His team is responsible for bringing research candidates into clinic and commercialization. Technology is focused around developing ImmTAC as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics, and other proteins. He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late-stage programs.

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• AI and Process Control
• Process Modelling and Developability

Annu Uppal, in her role as Director, Scientific Affairs and Strategy, leads a team of scientists across USP regions to drive and support USPs scientific priorities. Her leadership focuses on spearheading scientific affairs activities to enhance stakeholder engagement, foster collaborations, influence regulatory decisions, and drive scientific impact. Furthermore, Annu leads pivotal initiatives such as USP's Science & Quality Framework and Knowledge Hubs for Multi-Attribute Methods, highlighting her dedication to advancing standards and scientific progress. Previously at SCIEX, she served as the global lead for mass spectrometry-based biopharma applications, specializing in physiochemical characterization and impurity profiling of biologics. Annu's areas of expertise include glycosylation analysis, MAM, native mode, and host cell protein analysis. She holds a Ph.D. in Biotechnology from Aligarh Muslim University, India and has authored numerous peer-reviewed manuscripts and book chapters. Annu also serves as faculty for the USP biologics education program on method development and validation.

• Next-Generation Analytical Methods

Process Development Scientist in EMEA, Laurens supports customers in the development and optimization of various downstream purification technologies (chromatography, TFF, clarification, sterile and viral filtration). He has gained knowledge about purification strategies and PAT tools for different kinds of biopharmaceuticals, including viral vectors and mRNA. He obtained his Master’s Degree in Industrial Biochemical Engineering at the University of Leuven (Belgium).

• Accelerating Analytical Development
• Next-Generation Analytical Methods
• AI and Process Control
• Process Modelling and Developability

Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

• Accelerating Analytical Development
• Process Modelling and Developability

Dr. Joaquim Vives, a biochemist with a PhD in Biochemistry, has extensive experience in R&D, focusing on cellular processes for therapeutic and diagnostic applications. He leads a research group at Banc de Sang i Teixits (Barcelona, Spain), developing Advanced Therapy Medicinal Products, and teaches at Universitat Autònoma de Barcelona. He has published 70+ articles, holds 3 patents, supervised 8 PhDs, and has served in leadership roles in scientific societies.

• Cell Culture and Cell Line Engineering - Part 2

Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was team leader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of protein-based drug candidates. From this, he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and, since 2012, Bjørn has been heading the CHO Cell Line Engineering project dedicated to the engineering of improved protein production cell factories, and since 2021 he has been heading the Cell Line and Protein Production in the National Biologics Facility at the Technical University of Denmark.

• Cell Culture and Cell Line Engineering - Part 2

Isabel Waibel received her master's degree in process engineering from the Karlsruhe Institute of Technology and the University of Michigan. She is currently a PhD student in Prof. Arosio’s Lab at the Institute of Chemical and Bioengineering, Department of Chemistry and Applied Biosciences. In her research, she is focusing on innovative methods for modulating the biophysical properties of protein therapeutics through sequence and formulation engineering.

• Accelerating Analytical Development
• Process Modelling and Developability

Patrick Werder is a research assistant in the Bioprocess Technology Group, led by Thomas Villiger, at the University of Applied Sciences Northwestern Switzerland (FHNW) in Muttenz. Recently completing his master’s degree in biotechnology, Patrick's research is centered on advancing plasmid production processes, where he drives the development of innovative and scalable solutions aimed at enhancing the efficiency and robustness of bioprocess workflows. His expertise extends to the optimization of production and purification protocols for complex biotechnological applications. Patrick holds a bachelor's degree in chemical engineering from FHNW, where his academic work focused on process development and the extraction and purification of natural compounds. He began his career with an apprenticeship at Novartis Pharma AG, gaining invaluable experience in process development and production of preclinical active pharmaceutical ingredients in a cGMP environment. In addition to his technical expertise, Patrick serves on the board of the ISPE Student Chapter at FHNW, where he fosters connections between academia and industry by organizing networking events that promote collaboration and engagement with industry leaders.

• Intensified and Continuous Processing

I am Associate Director, CMC at Complement Therapeutics in London. Prior to joining Complement I worked at Biogen, Nightstar Therapeutics and Cell & Gene Therapy Catapult. I have worked in Analytical development for most of my career and pivoted from supporting the development of In vitro diagnostics to Gene Therapy. I have gained >20 yrs experience in analytical development and half of this has been in supporting the development of Gene Therapies partnering with CDMOs. At Complement Therapeutics my role is to manage the CDMO and the associated activities and milestones to develop and deliver a gene therapy for the treatment of Geographic Atrophy.

• Gene Therapy CMC and Analytics

I studied Biotechnology at the Technical University of Brunswick in Germany between 1998-2004 which I finished with a diploma degree. I then did my PhD in the downstream group led by Prof. Juergen Hubbuch at the Research Centre in Juelich, Germany. The project which focussed on high throughput screening techniques in downstream processing was co-funded by Novo Nordisk where I was hired in 2007. I received my PhD (in German Dr.-Ing.) in 2008. Since 2007 I have worked in different positions in Novo Nordisk within the field of manufacturing/downstream processing of drug substances. I now work as Principal Scientist in a Manufacturing Development department with a focus on chromatography and filtration looking for faster, integrated processes and suitable in/on-line analytical techniques.

• Advances in Recovery and Purification - Part 1

Sisi Zhang is a principal scientist in the Analytical Chemistry group at Regeneron Pharmaceuticals. Her work in Regeneron is focused on host cell protein analysis and excipient analysis and published more than 10 first-author paper in these fields. Prior to Regeneron, she worked on metabolism at Princeton University. Sisi Zhang holds a BS in Pharmaceutical Sciences from Peking University and MS in Chemistry from Rutgers University.

• Next-Generation Analytical Methods
• AI and Process Control

Kyle Zingaro has 10+ years of experience leading technical and operational teams in preclinical through post-commercial development of biologics. Kyle is currently the UCB Head of Gene Therapy Process Sciences where he is accountable for leading the internal and external development of the manufacturing processes for UCBs gene therapy portfolio. Prior to joining UCB, Kyle was Head of Process Sciences at Thermo Fisher Scientific Viral Vector Services (formerly Brammer Bio) where he was responsible for leading commercial stage tech transfer and late-phase process development of Thermo Fisher's cell & gene therapy offerings. He holds a B.S. in biochemistry from Virginia Tech and a Ph.D. in chemical engineering from University of Delaware.

• Gene Therapy Manufacturing