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CMC of Protein and Antibody Therapeutics: Fundamentals, Best Practices, and Regulatory Strategies
This workshop will cover all key functions of Chemistry, Manufacturing and Control (CMC) of recombinant protein and antibody therapeutics. Designed for both experts seeking cross-functional insights and new entrants from academia or industry, it will provide a clear understanding of how all CMC functions connect. The attendees will gain a knowledge of the current best practices and emerging trends across the CMC landscape—from process and analytical development to formulation, manufacturing and regulatory considerations. Subject-matter experts will share their real-world experiences and provide their perspectives on the future practices. Join us to strengthen your CMC knowledge, broaden your perspective, and network with peers shaping the future of biotherapeutic development
Outline:
- Generation of production cell line and cell banking,
- Upstream Process Development,
- Downstream Process Development,
- Analytical Development,
- Drug substance production and scale up,
- Formulation and drug product development,
- Regulatory CMC and Quality Assurance.
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