MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs

Thomas Jefferson University, in collaboration with Temple University School of Pharmacy, proudly announces the launch of the new Master of Science (MS) in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs (ABMRA) degree program in the Fall 2022 semester.

While global pharmaceutical companies continue to discover new small-molecule therapeutic agents, an important paradigm shift to large-molecule biopharmaceutical products, as well as individualized medicines (advanced biotherapeutics) has been made possible due to new advances in the biotechnology and bioprocessing communities. 

Originally focused on protein replacement and monoclonal antibody-based therapies, the profoundly rapid development and production of new therapeutics like cell and gene therapies (CGT) and COVID-19 vaccines based on messenger-RNA technology has further expanded the market and the need for a skilled and trained workforce. This expansion affects every aspect of drug development, including manufacturing techniques, analytical methods and regulatory processes.

The MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs program has been established to address the shortage of individuals trained in regulatory affairs and the manufacturing process of biotherapeutic agents. As this is a highly specialized industry, starting salaries are approximately $90,000.

The MS in ABMRA program leverages the strengths of two regional institutions to provide an academic nexus for workforce development in the growing field of manufacturing and development of biologics and biosimilars:

• Thomas Jefferson University will offer didactic and laboratory-based courses in which students earn valuable hands-on experience and theoretic knowledge regarding the development, manufacture and analytical processes associated with the production of biopharmaceutical therapeutics. The courses will be offered at the state-of-the-art Jefferson Institute for Bioprocessing (JIB) located in the Spring House Innovation Park in Lower Gwynedd, Pennsylvania.
• Temple University’s Regulatory Affairs and Quality Assurance (RAQA) graduate program will provide courses in regulatory science practices, strategies and quality assurance expectations, providing students with a solid foundation in the practical application of RAQA, which is critical to the development and manufacture of biopharmaceutical products.
• There is currently a shortage of trained professionals in biopharmaceutical manufacturing. The ground-breaking ABMRA degree will serve as a major vehicle for professional workforce development both locally and nationally.