Core Principles and Best Practices for Biotech Analytical Test Methods across the Product Lifecycle (Part of Biotherapeutics Analytical Summit 2018)

Topics

• Outline of types of test methods typically used with biotech/biosimilar products for characterization, comparability, similarity, release and stability testing
• Overview of ICH, FDA and EU guidance documents associated with method validation and data integrity for in-house and contract testing labs
• Differences in study designs between qualification, validation, verification, tech transfer and bridging for biotech/biosimilar products
• Illustration of typical method lifecycle events for test methods (optimization, qualification, validation, method changes, method transfer, method replacement)
• Risks to data from non-GMP R&D labs at each phase of development and for key CMC analytical studies
• Overview of data integrity expectations for GMP analytical testing labs
• Illustration of best-practices for lab quality and data integrity for non-GMP R&D labs