MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs


Kanbar College of Design, Engineering & Commerce


Master of Science


East Falls


Hybrid (Online and On Campus)

Enrollment Options

Part Time

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