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

  • 13-14 Mar 2018
  • Sheraton Inner Harbor Hotel, Baltimore, MD, United States

Description

The Core Principles and Best Practices for Biotech Analytical Test Methods across the Product Lifecycle (Part of Biotherapeutics Analytical Summit 2018) covers topics such as:

  • 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

Past Events

Important

Please, check "Core Principles and Best Practices for Biotech Analytical Test Methods across the Product Lifecycle (Part of Biotherapeutics Analytical Summit)" official website for possible changes, before making any traveling arrangements

Event Categories

Science: Life Sciences & Biology
Technology: Biotechnology

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