Advanced Biotherapeutics: Manufacturing and Regulatory Affairs MS
The Master of Science in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs in the School of Pharmacy at Temple University launched in fall 2022 in collaboration with the Thomas Jefferson University’s Institute of Bioprocessing.
What is biotherapeutic manufacturing?
Biotherapeutic manufacturing is the process for which biotechnology is used to develop biological medicinal products. While global companies continue to discover new, small-molecule therapeutic agents, an important paradigm shift to large-molecule, biopharmaceutical products as well as individualized medicine (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 such as cell and gene therapies and COVID-19 vaccines based on messenger-RNA technology has further expanded the market and the need for a skilled and knowledgeable workforce. This program addresses the need for professionals with biotherapeutic manufacturing expertise.
This expansion affects every aspect of drug development, including manufacturing techniques, analytical methods and regulatory processes.