College
Kanbar College of Design, Engineering & Commerce
Degree
Master of Science
Campus
East Falls
Format
Hybrid (Online and On Campus)
Contact Information
Learning Objectives
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