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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
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)
Tiffany D. Rau, PhD, Owner, Rau Consulting LLC
TS10A: Holistic Data Management and Digital Twins for the Bioprocess Life Cycle
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.
- 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
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
- 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
Varsha Daswani, PhD, PMP, Senior Director, Analytics and Data Science, Lumilytics
TS9B: Comparability and Potency Assays for Cell, Gene and Biotech Products
- 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.
TS11B: Introduction to CMC for Biotech, Cell & Gene Therapy Products
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
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