トレーニングセミナー | 16th Annual Bioprocessing Summit 2024 公式サイト

当会議のトレーニングセミナーでは、また学術的理論とその背景事情を幅広く取り上げると共に、実際のケーススタディや直面した課題、適用された解決策などを提供します。学習体験を最大化するために、各セミナーでは公式の講義とインタラクティブディスカッション、アクティビティを組み合わせています。経験豊富な講師陣のもと、現在の研究に適用可能な内容に焦点を合わせ、その分野に慣れていない人へ重要なサポートをします。

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8月19日（月） 10:00 am - 3:30 pm | 2024年8月20日（火） 8:00 am - 1:00 pm

TS9A: Introduction to Bioprocessing - Discovery to Commercialization

The seminar will introduce participants to bioprocessing from a process development, manufacturing and regulatory perspective. The seminar will follow a “molecule” from discovery to commercialization that is produced using mammalian cell culture and the different unit operations will be introduced as well as CMC considerations. In addition, different modalities will be explored with regards to opportunities and challenges in development and production methods such as production of Advanced Therapies (Cell and Gene Therapies). In addition, data and its analysis is a critical component to ensure process understanding and minimize CMC challenges and best practices for data management and new statistical methods and tools will be introduced.

Topics to be covered:

Upstream Bioprocessing: Mammalian Expression Systems
Downstream/Purification Bioprocessing
Scale-Up and Scale-Down Considerations
Chemistry, Manufacturing, and Control (CMC) Pathway, and Program Design Considerations
Overview and Considerations for Development and Manufacturing of Advanced Therapies: Cell and Gene
Avoiding Data Lakes and Leveraging New Methods for Data Analysis Using Modern DoE and Prediction
Next-Generation Processes: Continuous Manufacturing, etc.

Who Should Attend:

Bioprocessing Scientists and Engineers in Process Development, Research and Development, Manufacturing Science. CMC, Quality Assurance, etc.

INSTRUCTOR BIOGRAPHIES:

Martin Hurley, Managing Director, BioPharma Technical Consulting (BPTC)

Martin Hurley is the director and co-founder of Bio Pharma Technical Consulting, a consultancy that partners with clients to deliver expertise in CMC, Cell & Gene Therapy, Tech Transfer, GAMP5 in the Biopharma and Pharma space. He brings 30+ years of international Automation, System development (SCADA), and PM experience in electronics, pharma industries. Prior to establishing BPTC, Martin was Applications Systems Manager EMEA with Elanco Animal Health (a division of Eli Lilly until 2019) where he liaised with scientists and equipment vendors to develop and deliver high-end enzyme application systems and solutions. Martin also worked with Eli Lilly in the Caribbean Island of Puerto Rico where, as a member of the Capacity Expansion Team, he managed business critical projects involving application of lean strategies to optimize CSV processes to meet or exceed regulatory expectations. Previous roles include software engineering in the electronics industry (Apple Computer) and SCADA development/deployment (Gilroy Automation) for clients in the Pharma industry. In Summary: Martin is analytical and strategy-oriented, with experience in large-scale multiphase and high-profile projects in a variety of areas including automation, equipment deployment and capacity expansions in a GMP environment.

Tiffany D. Rau, PhD, Owner, Rau Consulting LLC

Tiffany D Rau, Ph.D., Owner and Principal Consultant of Rau Consulting and is an expert in bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing. Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems. Previously, Dr. Rau has held leadership positions at Evonik-Degussa, Eli Lilly, Pall and GlaxoSmithKline all focused in process development, tech transfer, commercial manufacturing, and CMC strategy. Dr. Rau has over 75 invited speaking engagements focused on delivering current and next-generation products from R and D to commercialization/post-commercialization. Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.

TS10A: Holistic Data Management and Digital Twins for the Bioprocess Life Cycle

Regulatory expectations for statistically underpinned Process Validation (PV) have found their way into current guidelines leading to demonstrating Established Conditions (ECs) in ICH Q12. However, successful and accelerated biopharmaceutical process validation (Stage 1-3) remains unresolved in industrial practice. This is due to the necessity of using scale-down models, the cost-intensive setup of experiments, and the complexity due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches will be a success factor in this endeavor.

This training seminar will focus on:

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy.
Methods and best practices embedded in workflows based on data science and digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Contemporary and novel approaches to accelerate process development, efficiently gaining CMC process understanding for meeting Stage 1 Validation expectations.

Learning Objectives:

Understand regulatory perspectives on challenges and concerns in bioprocess validation.
Gain insights into new tools and workflows to target critical components towards a successful bioprocess stage 1 validation and technology transfer.
Gain hands on experience in solving challenges for bioprocess validation, such as scale down model qualification, experimental design & evaluation, as well as setting up a control strategy.
Understand challenges in process validation life cycle. Explore challenges and emerging solutions in process validation for current and next generation bioproducts.
See the potential of digital twins for accelerating the product life cycle and increase process robustness.
Participate in demonstrated application through review of multiple case studies.

INSTRUCTOR BIOGRAPHIES:

Christoph Herwig, PhD, former Professor, Bioprocess Engineering, Vienna University of Technology; CPO, Fermify GmbH; Senior Scientific Advisor, Körber Pharma Austria

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.

2024年8月21日（水） 8:00 am - 3:00 pm | 2024年8月22日（木） 8:00 am - 12:00 pm

TS8B: Introduction to Machine Learning and Artificial Intelligence for Bioprocessing Applications

What does it take to be AI ready? Join us for an interactive 1.5-day training where we examine how to implement generative AI, large language models, and machine learning tools for a bioprocessing organization. We’ll define proper use case requirements, explore the necessary components of data integrity, and outline how to go from a proof-of-concept to the deployment of a production level solution. Join us as we play games, compete for prizes, and learn what it means to create a truly fit for purpose digital solution.

Recent advancements in AI technology
Use cases in bioprocessing
“Good data”-how do scientists and data scientists define that differently
Data standardization
Create well defined data
Ensure your dataset is representative
Communicating clear use case requirements
Choosing the right tool or model
Data cleansing-what is it and why does it always take so long
Data security and what that means for bringing in new technology
How to go from proof-of-concept to production

INSTRUCTOR BIOGRAPHIES:

Avinash Dalal PhD, Director, Data Science, Lumilytics

Avinash Dalal Ph.D. is director of data science at Lumilytics. His team works to build fit for purpose solutions for pharmaceutical drug development by applying generative AI and computational modeling. Prior to Lumilytics, Avi worked as a principal data scientist leading development and deployment of AI and modeling solutions in biotherapeutics at Pfizer. Prior to joining Pfizer, he worked in forecasting for the retail market and was also a tenure-track professor in mathematics & statistics. He has his Ph.D. in mathematicsfrom Drexel University where his work was in algebraic combinatorics and geometry.

Varsha Daswani, PhD, PMP, Senior Director, Analytics and Data Science, Lumilytics

Varsha Daswani, Ph.D. PMP, is the senior director of analytics and data science at Lumilytics. Her team works to adapt and advance generative AI, natural language processing, and machine learning tools to create fit for purpose solutions for pharmaceutical drug development. Prior to joining Lumilytics, Varsha worked at both Pfizer and Janssen. Most recently at Pfizer, she led the large molecule data science group. She has her Ph.D. in Biochemistry from Temple University where she developed a novel liposome encapsulation method for small molecule chemotherapeutic agents.

TS9B: Comparability and Potency Assays for Cell, Gene and Biotech Products

Comparability studies following process changes are a critical component of drug development, impacting both CMC (Chemistry, Manufacturing, and Controls) and process development teams significantly. Robust potency assays are crucial not only for these studies but also for process validation and stability testing. This 1.5-day training seminar offers a comprehensive exploration of regulatory science and biological standardization in biologics. The seminar details the nature of potency, highlights the differences in potency assays across biotech and cell and gene therapy products, and discusses the principles of comparability and their varied applications across these sectors.

Topic to be covered:

Challenges posed by the structural complexity of products like viral vectors and cell-based products.
Characterisation Strategy: Physicochemical and Biological
What is potency, and what is it not?
Reference materials
Manufacturing Process as a Determinant of Product Quality
Examination of the manufacturing process's influence on the final product's quality
How comparability is assessed when changes are made to the manufacturing process
Comparability: New Draft FDA Guideline
Deep Dive into Case Study: Erythropoietin
Navigating Regulatory Landscapes
Group Exercise on Comparability Data Requirements
Challenges in Scaling Up Production
Implementing Robust Process Control Strategies
Designing and Implementing Comparability Studies
Case Studies on Regulatory Success
Advanced Analytical Techniques for ATMP Characterization
Future of ATMPs
Emerging Technologies in ATMP Manufacturing

Who should attend:

The course is beneficial to cell and gene therapy professionals working in technical development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

TS11B: Introduction to CMC for Biotech, Cell & Gene Therapy Products

The chemistry manufacturing and controls (CMC) of biologics is a multidiscipline technical operation of bioprocess, analytics, dosage formulation, and cGMP manufacturing/testing for DS/DP release and stability to treat human diseases. This interactive training course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, monoclonal antibodies (Mab), and cell and gene therapy (CGT) in the context of IMPD and IND regulatory filing. Attendees will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirements. The instructor will present common pitfalls and share the best industry practices. Numerous real-world regulatory queries/comments from health authorities worldwide will be exemplified as case studies during the training course.

TOPICS TO BE COVERED:

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

2. Overview of CMC guidance documents (ICH, FDA, EMA, USP, EP)

3. Quality by design (QbD), quality target product profile (QTPP), and critical quality attributes (CQA)

4. Manufacturing process of protein therapeutics, cell and gene therapy products

5. What are the CMC activities required for IMPD/IND regulatory filing (eCTD Module 3)

6. Cell line development for biotech, cell and gene therapy products

7. Diverse analytical procedures for biological products, method development (ICH Q14 2024), method validation (ICH Q2(R2) 2024), and lifecycle management

8. Formulation development and DP compatibility study for patient dosing

9. Manufacturing process development and control strategy

10. Process validation and manufacture of sterile medicinal products (EU GMP Annex 1)

11. Reference material generation, characterisation, certification, and annual qualification

12. DS/DP Specifications for batch release and ICH real time stability for expiry assignment

13. Manufacturing process changes: CMC analytical comparability exercise

14. Concluding remarks

WHO SHOULD ATTEND:

The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, 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.

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