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. 

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 expansion affects every aspect of drug development, including manufacturing techniques, analytical methods and regulatory processes. 

Temple University and Thomas Jefferson University 

The Advanced Biotherapeutics: Manufacturing and Regulatory Affairs MS program addresses the shortage of individuals trained in regulatory affairs and the manufacturing process of biotherapeutic agents. The degree unites 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. 

• Temple University’s regulatory affairs (RA) and quality assurance (QA) graduate program provides courses in regulatory science practices, strategies and quality assurance expectations, providing a solid foundation in the practical applications of RA and QA, which is critical to the development and manufacture of biopharmaceutical products. 

• Thomas Jefferson University’s Institute of Bioprocessing offers didactic and laboratory-based courses providing students with valuable hands-on experience in the development, manufacturing and analytical processes associated with the production of biopharmaceutical therapeutics. The courses are offered at the state-of-the-art Jefferson Institute located in the Spring House Innovation Park in Lower Gwynedd, Pennsylvania.

This groundbreaking master’s degree serves as a major vehicle for professional workforce development both locally and nationally. The curriculum combines theoretical and hands-on manufacturing process and analytical experience with mandated regulatory and quality assurance expectations that are essential to establishing and verifying good manufacturing, laboratory, clinical and pharmacovigilance practices. Starting salaries in this specialized industry start at approximately $90,000. 

Learn more about the program at Thomas Jefferson University. 

Learning Objectives 

Students completing the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs 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 nonclinical 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 biosimilars manufacture 

• 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

Program Format & Curriculum  

Each university will offer its own MS degree comprised of 36 credits. Students will have the choice of receiving the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs from either Temple University or Thomas Jefferson University, depending upon their area of interest. 

• Manufacturing at Thomas Jefferson University 

• Regulatory affairs at Temple University 

Students with a greater interest in the manufacturing process are required to submit a formal application for admission to Thomas Jefferson University, and students with a greater interest in regulatory affairs should submit a formal application for admission to Temple University. In either instance the student will complete an informal nondegree-seeking application to the partner institution to enroll in courses and transfer or apply the required credits to their home school. 

• Each university will provide 15 credits of course work towards the MS degree (for a total of 30 credits between the two schools). 

• Students select the remaining six credits (of the required 36) based on their individual interest, focusing on manufacturing at Jefferson or RA and QA principles through Temple. 

Students must complete 15 credits in Temple RA and QA courses (four courses are required and one is an elective).  

Required Courses 

• Drug Development (5459) 

• Biologics/Biosimilars: A Regulatory Overview (5515)  

• Global CMCs—Biologics (5577) 

• Vaccines: RA and QA Aspects (5572) 

Elective Courses

Students then choose at least one course from the following elective RA and QA courses. 

• Biotechnology: Bioprocess Basics (5471) 

• Pharmaceutical Biotechnology (8005) 

• Statistical Quality Control (5451) 

• Validation of FUE (Facilities, Utilities, and Equipment (5468) 

• Process Validation (5474) 

• Advanced Good Manufacturing Practices – Defining “c” (5479) 

• Production of Sterile Products (5492)  

• Sterilization Processes (5493) 

• Development of Sterile Products (5501) 

• Microbiological Concepts in Pharmaceutical Manufacturing (5512)  

• Regulatory Submissions (5514) 

• Cleaning Validation (5516) 

• Clinical Drug Safety and Pharmacovigilance (5538*)  

• Regulatory Intelligence (5544) 

• Post-Marketing Safety Surveillance (5571*)   

• Quality Systems Management (5574) 

• Regulatory Sciences: Managing the Guidelines for Quality (5575) 

• Process Analytical Technology (PAT) (5625) 

• Statistical Design of Experiments (DOE) (5627) 

• Process Monitoring (5629) 

*Students may pursue one or the other course, but not both. 

Thomas Jefferson University’s Institute of Bioprocessing Courses

Students must also complete a minimum of 15 credits in biopharmaceutical manufacturing from Thomas Jefferson University’s Institute of Bioprocessing, including the following required courses. 

• Bioprocess Engineering for Scientists (ENGR 609)  

• Introduction to Biopharmaceutical and Biologics Production (ENGR 621)

• Principles of Biopharmaceutical Process Engineering (ENGR 611)  

• Biopharmaceutical Process Operations (ENGR 604) ​

Students must take three more credits from the following Institute of Bioprocessing electives. 

• Introduction to Upstream Unit Operations: Cell Culture and Harvesting (ENGR 601) 

• Introduction to Downstream Unit Operations:  Purification, Buffer Exchange and Concentration ENGR 602) 

• QbD, Process Selection and Optimization (ENGR 605) 

• Vector and Cell Line Design (ENGR 613) 

• Biotherapeutic Formulation (ENGR 622) 

• Vaccine Formulation (ENGR 614) 

• Technical and Regulatory Aspects of Analytical Method Validation (ENGR 618) 

• Emerging Therapeutics (ENGR 612) 

Requirements 

Students must have a science or engineering degree at the undergraduate or graduate level with an overall GPA of 3.0 to pursue the MS.