Thursday, November 5, 2020 | 8:30 AM 11:30 AM

Thursday, November 12, 2020 | 8:30 AM 11:30 AM

Thursday, November 19, 2020 | 8:30 AM 11:30 AM

Lead Instructor: Christine Chan

Christine P. Chan, PhD, Director, Global Manufacturing Science & Technology, Sanofi

Dr. Christine Chan is a protein biochemist with broad experience in the biopharmaceutical industry, including prior experience at Sandoz Pharmaceuticals and Merck & Co., Inc. She specializes in the analysis of recombinant products produced from mammalian cells for vaccines and biologics development. Her application experience includes expression cell line selection, drug substance & drug product process development, manufacturing technology transfers, and lifecycle management of commercialized products. Dr. Chan received her Ph.D. from the University of California-Davis and conducted post-doctoral work at the University of Washington. She has authored over 30 publications with two recent reviews on forced degradation studies on protein-based therapeutics and stability testing considerations.

Series Description

Biotherapeutics are challenging to develop due to the complexity of the molecular structure, as well as the manufacturing process. In this workshop, we will discuss the key concepts of CQA risk ranking based on potential impact on safety and efficacy, the analytical characterization technologies commonly used, defining bioprocess impact on product quality & stability, and the considerations for development of an integrated testing strategy.

Who Should Attend

Scientists, Engineers and Managers in Biotherapeutics Development with CMC job functions, including Research & Development, Technical Operations, Quality Control & Assurance, Regulatory Affairs and Project Management groups, with interest in Analytical Development and Applications.

Part 1: Critical Quality Attributes Assessment & Analytical Characterization

Identification of product critical quality attributes (CQAs) is an important component in the development of a robust control strategy using the Quality-by-Design approach. In Module 1 of the workshop, we will discuss the key concepts of CQA risk ranking based on potential impact on safety and efficacy. Analytical characterization technologies commonly used in product quality assessment will be highlighted.

Part 1 Topics to be Covered:

1. Introduction & Background:
• Product development stages & lifecycle management
• CMC elements in regulatory dossier: CTD Module 3 sections
2. CQA Criticality Assessment:
• Product-related variants, process-related impurities
• Leveraging prior knowledge and gathering product structure-function relationship information
• Defining acceptable ranges through development stages
3. Analytical Characterization Approaches:
• Quality assessment categories
• Multiple orthogonal techniques: Biochemical & biophysical methods
4. Practical Examples & Discussion

Part 2: Bioprocess Impact on Product Quality and Stability

Process characterization is essential in establishing robust control of parameters that may impact product quality and stability. In Module 2 of the workshop, we will discuss understanding of the linkages between process operations and potential impact on product quality. The various types of stability studies in support of product development will be summarized.

Part 2 Topics to be Covered:

1. Introduction: Quality by Design Approach & Risk Assessment
2. 2) From CQA Definition to Process Impact Mapping:
• Process operations overview & potential impacts on product quality
• Process analytics applications: Product attributes monitoring, impurities control
3. 3) Stability Profile & Monitoring:
• Defining product stability profile, higher-order structure characterization
• Stress study conditions: Product instability & process/manufacturing operations
• Long-term stability and accelerated stability studies
4. 4) Facilitated Discussion: Sharing Experiences

Part 3: Testing Strategy and Comparability Exercise

The establishment of an integrated control strategy for robust manufacturing is an iterative process based on sound science and quality risk management. In Module 3 of the workshop, we will discuss key considerations in evolving the analytical control strategy through the course of product development. The hierarchical assessment approach to demonstrating comparability of the product in support of process changes will also be discussed.

Part 3 Topics to be Covered:

1. Introduction: Overview of Control Strategy over the Product Lifecycle
2. Defining Testing Strategies:
• What to test, tests to use, control points
• Assay method lifecycle
• Evolving the test panel & specifications through the product lifecycle
3. Comparability Exercise Planning:
• Types of manufacturing changes & level of testing
• Forced degradation studies in support of comparability demonstration
• Setting pre-defined comparability criteria, addressing analytical differences
• Risk-based impact assessment
• Simulated case studies discussion