Wednesday, March 14, 2018 : 6:00 – 8:30pm (Dinner provided)

SC3: Critical Quality Attributes and Testing Strategy for Biotherapeutics Development

Instructor:
Christine Chan, Ph.D., Principal Scientist /Technical Lead, Global Manufacturing Sciences & Technology, Sanofi

Introduction

Biotherapuetics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. 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 this short course, we will discuss the key concepts of CQA risk ranking based on potential impact on safety and efficacy, defining control strategies, the common analytical characterization technologies used, and the considerations for development of an integrated testing strategy.

Course Outline:

• CQA criticality assessment: leveraging prior knowledge and gathering product structure-function relationship (SAR) information; acceptable ranges through development stages
• Analytical characterization strategy and test methods selection: commonly used assays and emerging tools. Conducting forced degradation studies; product stability profile
• Linkage of process to product quality: defining control strategies, comparability studies
• Towards a streamlined testing strategy: evolving the test panel and specifications through the product lifecycle
• Practical examples and discussions

Biography

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 tech transfers and lifecycle management of commercialized products.