Global Certificate Biosimilars: Advanced Manufacturing
-- ViewingNowThe Global Certificate in Biosimilars: Advanced Manufacturing is a comprehensive course that addresses the growing demand for expertise in the field of biosimilars. This certification equips learners with critical skills required to excel in this high-growth area of the pharmaceutical industry.
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โข Biosimilars Fundamentals: Introduction to Biosimilars, Regulatory Guidelines, Quality Attributes
โข Cell Line Development: Cell Line Engineering, Cell Culture Techniques, Upstream Process Development
โข Expression System: Selection, Characterization, and Optimization of Expression Systems
โข Downstream Processing: Purification Technologies, Virus Removal Strategies
โข Analytical Methods: Characterization, Comparability, and Quality Control Assays
โข Formulation and Fill/Finish: Excipient Selection, Container Closure Systems, Sterile Manufacturing
โข Regulatory Affairs: Regulatory Strategies, Global Submissions, Post-Approval Life Cycle Management
โข Quality Management: Quality by Design, Risk Management, Change Management
โข Biopharmaceutical Industry Trends: Market Analysis, Intellectual Property, Collaborative Partnerships
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