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MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) in conjunction with Thomas Jefferson University

Thomas Jefferson University

Temple University School of Pharmacy proudly announces the launch of the new Master of Science (MS) in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) in collaboration with the Thomas Jefferson University's Institute of Bioprocessing (JIB) in the Fall 2022 semester.

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 advanced 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 (CGT) 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. 

The MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs program will address 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 RAQA graduate program will provide courses in regulatory science practices, strategies and quality assurance expectations, providing a solid foundation in the practical applications of RAQA, which is critical to the development and manufacture of biopharmaceutical products.
•    Thomas Jefferson University’s Institute of Bioprocessing (JIB) will offer 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 will be offered at the state-of-the-art Jefferson Institute of Bioprocessing (JIB) located in the Spring House Innovation Park in Lower Gwynedd, PA. 

The ground-breaking AMBRA degree will serve as a major vehicle for professional work-force 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. 

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 (ABMRA) from either Temple or Thomas Jefferson University, depending upon their area of interest: manufacturing (TUJ) or Regulatory Affairs (TU).

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 “non-degree” seeking application to the partner institution to enroll in courses and transfer/apply the require 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 6 credits (of the required 36) based on their individual interest, focusing on manufacturing at Jefferson or RAQA principles through Temple. 

Students must complete 15 credits in Temple RAQA courses (four courses are required and one is an elective).  The required courses are:

•    Drug Development (5459) 
•    Biologics/Biosimilars: A Regulatory Overview (5515) 
•    Global CMCs - Biologics (5577)
•    Vaccines:  RA and QA Aspects (5572)

Students then choose at least one course from the following elective RAQA courses. 
o    Biotechnology: Bioprocess Basics (5471)
o    Pharmaceutical Biotechnology (8005)
o    Statistical Quality Control (5451)
o    Validation of FUE (Facilities, Utilities, and Equipment (5468)
o    Process Validation (5474)
o    Advanced Good Manufacturing Practices – Defining “c” (5479)
o    Production of Sterile Products (5492) 
o    Sterilization Processes (5493)
o    Development of Sterile Products (5501)
o    Microbiological Concepts in Pharmaceutical Manufacturing (5512) 
o    Regulatory eSubmissions (5514)
o    Cleaning Validation (5516)
o    Clinical Drug Safety and Pharmacovigilance (5538*) 
o    Regulatory Intelligence (5544)
o    Post-Marketing Safety Surveillance (5571*)  
o    Quality Systems Management (5574)
o    Regulatory Sciences:  Managing the Guidelines for Quality (5575)
o    Process Analytical Technology (PAT) (5625)
o    Statistical Design of Experiments (DOE) (5627)
o    Process Monitoring (5629) 

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

Students must also complete a minimum of 15 credits in biopharmaceutical manufacturing from JIB, including the following required courses: 

o    ENGR 609 – Bioprocess Engineering for Scientists  (3 credits)
o    ENGR 621 – Introduction to Biopharmaceutical and Biologics Production (3 credits)
o    ENGR 611 – Principles of Biopharmaceutical Process Engineering (3 credits)
o    ENGR 604 – Biopharmaceutical Process Operations (3 credits)
 
Students must take 3 more credits from the following JIB electives: 
 
o    ENGR 601 – Introduction to Upstream Unit Operations: Cell Culture and Harvesting (3 credits)
o    ENGR 602 – Introduction to Downstream Unit Operations:  Purification, Buffer Exchange and Concentration (3 credits)
o    ENGR 605 – QbD, Process Selection and Optimization (1.5 credits)
o    ENGR 613 – Vector and Cell Line Design (3 credits)
o    ENGR 622 – Biotherapeutic Formulation (3 credits)
o    ENGR 614 – Vaccine Formulation (1.5 credits)
o    ENGR 618 – Technical and Regulatory Aspects of Analytical Method Validation (1.5 credits)
o    ENGR 612 – Emerging Therapeutics (1.5 credits)

Other electives from both schools courses may become available over time.

Each University will offer its own MS in Advanced Biotherapeutics:  Manufacturing and Regulatory Affairs degree comprised of a total of 36 credits.  Students have the choice of receiving the degree from either Temple 

LEARNING OBJECTIVES
Students completing the M.S. 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 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 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.

At TUSP, Regulatory Affairs and Quality Assurance continue to be viewed as co-equal components in the success of the nation’s oldest and most nationally recognized program of its type. Its targeted recruitment initiatives have consistently promoted strong industry and FDA- based faculty, which, along with the program’s individualized student services have provided it strong foundation and content-dense curriculum.

Anticipating the biopharmaceutical phase-shift and growth as well as the need for appropriately trained personnel, Thomas Jefferson University established the Jefferson Institute for Bioprocessing (JIB), a state-of-the-art facility fully equipped with the latest biopharmaceutical manufacturing equipment.  Located in the Spring House Innovation Park in Lower Gwynedd, PA, JIB is constructed as a hands-on instructional facility to develop the next generation of individuals qualified to conduct the specialized manufacturing and quality assurance aspects essential to the successful and safe production of therapeutic biomaterials, based on the “continuous manufacturing,” used for smaller, individualized batches.

Academic 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.