トレーニングセミナー | 16th Annual PEGS Europe - Protein & Antibody Engineering Summit 2024 公式サイト

Training Seminars by Cambridge Healthtech Institute

Cambridge Healthtech Instituteのトレーニングセミナーでは、学術的理論やその背景事情について幅広く取り上げると共に、実際の事例研究や、直面した課題と適用された解決策についての情報を提供します。各々のトレーニングセミナーでは、フォーマルな講義とインタラクティブな議論・活動を組み合わせて、学習効果を最大化させています。熟練した講師がトレーニングセミナーを主催し、現在の研究内容に適用可能なコンテンツに焦点を当てて、その分野の初心者向けに重要なガイダンスを提供します。

トレーニングセミナーは対面形式でのみ開催されます。

2024年11月5日（火） 08:25 - 18:35

TS7A: Introduction to Machine Learning for Biologics Design

This course offers an introduction to concepts, strategies, and machine learning methods used for biologics design. It includes presentations and demonstrations of the methods used in the field, covering techniques such as triaging sequences, modulating affinity, and designing antibody libraries, along with increasing manufacturability. The course is directed at scientists new to the field and protein engineers wanting an introduction to how machine learning can aid in guiding biologics design.

INSTRUCTOR BIOGRAPHIES:

Christopher R. Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Dr. Christopher Corbeil is a research officer at the National Research Council Canada (NRC) who specializes in the development and application of computational tools for biotherapeutic design and optimization. He is also an associate member of the McGill Biochemistry Department and teaches classes in Structure-Based Drug Design at McGill University. After receiving his PhD from McGill University, he joined the NRC as a Research Associate investigating the basics of protein-binding affinity. Following his time at the NRC he joined Chemical Computing Group as a research scientist developing tools for protein design, structure prediction, and binding affinity prediction. He then decided to leave private industry and rejoin NRC with a focus on antibody engineering. Dr. Corbeil has authored over 30 scientific articles and is the main developer of multiple software programs.

TS8A: Introduction to Multispecific Antibodies: History, Engineering, and Application

Introduction to Multispecific Antibodies will be organized as an informative and practical guide to getting up to speed on critical aspects of multispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction will span mechanisms of action, engineering, developability, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of multispecifics as targeted and immunomodulatory approaches will be discussed.

Topics to be Covered:

A brief history of bispecific antibodies: 60 years of progress with critical advances and key pioneers
Multispecific applications and powerful mechanisms-of-action
Engineering multispecific antibodies:100 formats and counting
Multispecific-specific considerations in preclinical development and regulatory landscape
Developability, manufacturing, and analytical considerations
Clinical experience, translation, and regulatory approval
Current trends and future opportunities in regulating immune checkpoints, cell-based therapies, and personalized approaches

INSTRUCTOR BIOGRAPHIES:

G. Jonah Rainey, PhD, Senior Director, Protein Engineering, Eli Lilly and Company

Jonah Rainey holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute. He has engaged in discovery, research, and development of bispecific antibodies for more than 15 years. He is an inventor on several patents describing novel bispecific platforms and current clinical candidates that exploit these platforms as well as an author on almost 30 publications. Jonah contributed to research and early development leading to multiple clinical candidates from Phase I and through approved products and led many advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Previous industry experience includes MacroGenics, MedImmune/AZ, Oriole Biotech, Gritstone Oncology, and Alivamab Discovery Services. Currently, Jonah is a Senior Director in Protein Science at Eli Lilly & Co.

TS9A: Current Applications of Host Expression Systems and Optimisation of the CEPA Workflow to Support Therapeutic Generation and Structural Biology

Protein production is more complex than just the act of expressing the proteins. This training seminar will review the end-to-end protein production CEPA (Cloning, Expression, Purification, Analytics) workflow process and focus on how to increase its efficiency and productivity. The choice of a suitable host expression system depends mainly on the biological and biochemical properties of an individual protein. We will review the concepts and applications of the major host expression systems, then turn our focus to the insect and mammalian systems, which have shown the ability to express complex proteins for a wide variety of applications. This seminar will combine instruction and current case studies in an interactive environment. It is recommended for scientists of all experience levels interested in addressing the demand for increasingly complex proteins within ever decreasing timelines.

Topics to be Covered:

Review of host expression systems and their application

Focus on eukaryotic expression systems

Producing recombinant proteins in insect cells

Transient and stable protein production in mammalian cells

Implementing and optimising the CEPA workflow

Addressing bottlenecks in harvesting/purification
Setting QC standards

Case Studies

Difficult-to-express proteins
Structural biology support
Automation/Screening
Scale-down/Scale-up

Agenda:

8:30 am Opening Remarks/Introductions

8:45 am Review of host expression systems and their applications

9:15 am Producing recombinant proteins in insect cells

10:30 am Coffee Break in the Exhibit Hall with Poster Viewing

11:15 am Transient and stable protein production in mammalian cells

12:45 pm Lunch

2:00 pm Implementing and Optimizing the CEPA Workflow

3:50 pm Refreshment Break in the Exhibit Hall with Poster Viewing

5:00 pm Case Studies (Difficult-to-express proteins, Structural biology support, Automation/Screening, Scale-down/Scale-up)

6:15 pm Closing remarks/Q&A

6:30 pm Close of Training Seminar

INSTRUCTOR BIOGRAPHIES:

Richard Altman, MS, Field Application Scientist, Life Science Solutions, Thermo Fisher Scientific

Rich Altman has 30 years of experience in protein expression and production. In early 2019, he joined Thermo Fisher Scientific as a Field Application Scientist. Previously, he worked for several pharmaceutical companies, including Amgen, Alexion, Bayer, and Upjohn, on the cloning, expression, purification and characterization of recombinant proteins. This work supported both small-molecule high-throughput screening and protein therapeutic efforts. He received his MS degree from the University of Pittsburgh School of Medicine in the Department of Molecular Biology and Biochemistry.

Henry C. Chiou, PhD, Senior Director General Manager, Biosciences, Thermo Fisher Scientific

Henry Chiou is Senior Director and General Manager for the Delivery and Protein Expression business within Biosciences at Thermo Fisher Scientific. He and his teams have developed products such as the Expi family of 293, CHO and Sf9-based expression systems, Lipofectamine 3000, and other Lipofectamine-family transfection reagents, production systems for cell and gene therapy viral vectors such as AAV MAX system. Henry has authored multiple publications on mammalian transient expression and frequently teaches courses and lectures on this subject. Prior to joining Thermo Fisher, Henry worked in small to mid-sized biotech companies on non-viral gene therapy. Henry received his doctorate from Harvard University in Molecular Pharmacology, following which he completed a postdoctoral fellowship in viral expression systems at the University of Pennsylvania.

Dominic Esposito, PhD, Director, Protein Sciences, Frederick National Laboratory

Dr. Esposito is currently the Director of the Protein Expression Laboratory (PEL) and Project Lead for the RAS Reagents Core at the Frederick National Laboratory for Cancer Research in Frederick, Maryland. The 38 employees in the PEL clone, express, and purify proteins from a variety of host organisms in support of the NCI RAS Initiative and for investigators at the National Institutes of Health. In addition, the PEL invents and develops novel technologies for improving protein expression and production, focused heavily on baculovirus expression technology and combinatorial cloning. Prior to his role as director, Dr. Esposito led the Clone Optimization Group in the PEL for nine years and was responsible for the generation of over 15,000 expression clones, 400 new expression vectors, and several technological innovations in protein expression. Dr. Esposito received his B.A. in Chemistry at La Salle University in Philadelphia, and his Ph.D. in Biochemistry in the laboratory of Dr. John Scocca at the Johns Hopkins University Bloomberg School where he studied bacteriophage site-specific recombination. Dr. Esposito then worked as a postdoctoral fellow in the laboratory of Dr. Robert Craigie at the NIDDK, where he studied the protein-DNA interactions involved in the HIV integration reaction. Prior to joining the FNL in 2001, Dr. Esposito worked for three years as a Staff Scientist in the Protein Engineering group at Life Technologies, where he helped to develop the Gateway recombinational cloning system. Dr. Esposito has published over 100 peer-reviewed manuscripts in the fields of protein expression and DNA recombination.

TS10A: Introduction to Analytical Characterisation and Method Validation for Biological Products

This interactive training seminar introduces a full spectrum of analytical procedures and characterization methods in biotech, gene and cell therapy product development. The instructor will update the new ICH guidelines on how to develop analytical procedures (Q14, 2024) and validate test methods (Q2(R2), 2024) in the context of IMPD/IND regulatory filing. Attendees will learn the practical aspects of the commonly used analytical procedures to address product identity, purity and impurity, strength and potency, process-related impurities and contaminants. The extended characterization will elaborate structure elucidation by mass spectroscopy, primary and secondary structure, post-translational modification, glycan profiling, charge variant analysis, biophysical characterization of higher order structure and aggregation. The class is for academics, newcomers in industry, and veterans wanting an update on analytical technologies.

Topics to be covered:

1. The diverse modality of therapeutic biological products: protein, gene, and cell therapy products

2. Analytical procedure development (new ICH Q14 2024) and validation (new ICH Q2(R2) 2024)

3. Product Stability: developability, forced degradation, pre-formulation, and formulation development

4. Product strength methods: protein concentration, DNA concentration, and viable cell density

5. Product purity/impurities methods: capillary electrophoresis (CE-SDS NR/R, cIEF, icIEF) and HPLC (IEX, RP, SEC, HIC, HILIC)

6. Product potency methods: biological activity (binding ELISA, functional activity, and CBPA)

7. Product identity methods: peptide mapping, sequencing, icIEF, binding ELISA, FCM

8. Product safety: methods of process impurities and contaminants for product safety (HCP by ELISA and MS, residual DNA, leachable ligand, mycoplasma, bioburden, endotoxin, sterility, and RMM)

9. Aggregate and sub-visible particle analysis (AUC, SEC-MALS, DLS, LO, FIM, MFI) to address immunogenicity concern

10. Extended characterisation by mass spectroscopy (LC-MS), multi-attribute method (MAM), charge variant analysis (CVA), glycan profile (HILIC and site-specific), sialic acid, qPCR, biosensor (SPR, BLI), and HOS by biophysical characterisation (CD, FS, DSC, DSF, TEM)

Who should attend?

The curriculum provides a broad overview of biologics analytical and characterisation strategies. It is beneficial to individuals involved in biologics drug discovery, developability assessment, analytical development, formulation development, process development, DS/DP manufacturing, quality control, quality assurance, clinical supply, regulatory affairs, CMC project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Senior Director, IGM Biosciences

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining IGM Biosciences, he held various positions in biologics CMC disciplines at Allergan, AnaptysBio, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.

2024年11月6日（水） 08:25 - 19:45

TS9B: Label-Free Biosensor Tools in Biotherapeutic Discovery: SPR, BLI and KinExA

This training seminar will cover the main applications and guidelines for best practices of commonly used commercial label-free biosensors in the interaction analysis of therapeutic antibodies. We will primarily focus on Surface Plasmon Resonance (SPR) and Kinetic Exclusion Assay (KinExA) technologies but will also address other surface (BLI) and solution (MSD and Gyrolab) methods. We will first cover the fundamental concepts used to design a binding kinetic experiment for affinity determination, then do a ‘deep dive’ into epitope binning and explore solution affinity methods with an emphasis on expanding throughput. In addition, we will showcase the complementary use of surface and solution approaches for determining affinities across a broad range of values to highlight their unique strengths and limitations.

BINDING KINETICS

Introducing binding kinetics and rate constants
Working principle of SPR
SPR best practices for generating high-quality kinetic data

EPITOPE BINNING

Assay formats (tandem, premix and classical sandwich)
Bin definition
Throughput
Nuanced binning (antigen heterogeneity, asymmetry, and displacement)

SOLUTION AFFINITY

Introducing the solution affinity method and its need
KinExA method and best practices
Data analysis and interpretation
Advanced applications (on-cell, and ultra-high affinities)
Expanding throughput using plate-based methods (MSD and Gyrolab)

COMPLEMENTARY USE OF SURFACE & SOLUTION METHODS FOR AFFINITY DETERMINATIONS

Case study from the literature

INSTRUCTOR BIOGRAPHIES:

Yasmina Abdiche, PhD, Vice President, Exploratory Research, OmniAb Inc.

Yasmina is an internationally recognized and innovative scientific leader in the field of antibody discovery and biosensors with twenty years of experience in protein engineering and biopharma. To date, she has authored over 45 peer-reviewed publications, had 25 patents granted in the therapeutic antibody space including a market-approved drug (Ajovy), presented over 50 times as an invited speaker globally, and has been involved in numerous industry-wide collaborations and scientific advisory groups. After a twelve-year career at Pfizer where she held positions of increasing responsibility from Principal Scientist to Research Fellow, more recently, Yasmina has held senior management roles at biotechnology companies and contract research organizations including Carterra (CSO), ImmunoPrecise Antibodies (CSO), ALX Oncology (Vice President Protein Science), Revelar (CSO and Co-Founder), and FairJourney Biologics (CTO). During her time as CSO at Carterra, she co-founded its antibody screening biosensor platform (the LSA) which has helped transform label-free interaction analysis in early-stage drug discovery. Yasmina has a Master's degree in Chemistry and a PhD in Biological Chemistry from Oxford University and did post-doctoral studies in biophysical interaction analysis at the University of Utah.

Palaniswami (Swami) Rathanaswami, PhD, CEO, PRSwami AbDev Inc.

World’s leading expert Scientist in Antibody affinity and kinetic characterization, especially for measuring femto molar affinities of antibodies for soluble and on-cell targets. World expert in solution binding measurements and using KinExA technology. Extensive user of SPR and BLI technologies. Experienced SME as Functional Lead for human therapeutic antibody programs and drug product development. Dedicated career to advancing medical research to alleviate disease and make individuals lives better. Consultant for leading biotech organizations on high throughput screening, affinity measurements and antibody drug product development. Did extensive research, over 40 years in the fields of Endocrine Biochemistry, Molecular Endocrinology, Inflammation Immunology-Rheumatology, Human therapeutic antibody generation, engineering and characterization (including immunization, high throughput binding and functional screening and very high affinity kinetic measurements). A key member of a team of 5 Scientists who developed SLAM technology for human therapeutic antibody generation and spun to a Canadian Biotech company - Immgenics Inc., and later acquired by Amgen. First Scientist to generate human antibodies by Single Cell RT-PCR amplification of V genes from antibody producing single B Cells, molecular cloning and express as full antibody. Published over 40 articles in very high impact Scientific Journals and inventor of over 20 scientific patents. Worked for Amgen 25+ years and generated over 100 human therapeutic antibodies of which about 5 are already used as pharmaceutical drugs in market. Invited speaker in national and international conferences, Universities and Research institutes across the globe. Chaired sessions in international conferences and seminars. Dr. Palaniswami Rathanaswami graduated in MSc (Biochemistry, Faculty of Medicine) and a PhD (Biochemistry), University of Madras, India.

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