MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs

Students completing the MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs degree program should be able to demonstrate knowledge in the following areas:

• A broad foundation in U.S. and global regulatory landscapes for biologics and biosimilars
• Regulatory strategies for non-clinical and clinical studies for biologics and biosimilar products
• Chemistry, Manufacturing and Control (CMC) strategies for biologics and biosimilars
• Phase-appropriate regulatory compliance elements applicable to biologics and biosimilars
• Fundamentals of Quality by Design (QbD) and fundamentals of Statistical Process Control principles as relevant to biologics and biosimilar manufacturing
• Mastery of core engineering, scientific regulatory and quality principles utilized in the development and manufacture of biopharmaceuticals, biologics and advanced therapies
• Biopharmaceutical manufacture operations, including bioreactor, chromatography, formulation and product concentration operations
• Process development concepts, from early to late phase development and launch