CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products 2016 is a course dedicated to regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products.
Topics
- The different stages of the lifecycle including pre-clinical, clinical trials, commercialisation and post-approval
- Comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products
- Product reference standards and successful comparability tests
- Analytical considerations for a wide variety of biopharmaceuticals including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates)
- Meaningful product specifications, forced degradation studies and tech transfer
- Successful comparability tests for biosimilars
- Critical elements of laboratory quality practices that significantly impact the reliability of test data from RD through to current GMP will be illustrated
- Changes in analytical methods and effective stability protocols
