Program Description
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.
As this is a highly specialized industry, starting salaries are approximately $90,000.
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.
Curriculum: 2 years; 30 credits
| Code | Title | Credits |
|---|---|---|
| Thomas Jefferson University Curriculum | ||
| ENGR 609 | Bioprocess Engineering for Sci | 3 |
| ENGR 621 | Intro Biopharm &Biologics Prod | 3 |
| ENGR 611 | Princ BioPharm Proc Engineerin | 3 |
| ENGR 604 | Biopharm Process Ops | 3 |
| Select at least one of the following: | 1.5-3 | |
| Intro Upstream Unit Operations | ||
| Intro Downstream Unit Ops | ||
EMGR 613 | ||
| Bio-Therapeutic Formulation | ||
| Vaccine Formulation | ||
| Tech & Regulatory Aspects | ||
| Emerging Therapeutics | ||
| Temple University Curriculum | ||
| 5459 | Drug Development | 3 |
| 5515 | Biologics / Biosimilars: A Regulatory Overview | 3 |
| 5575 | Global CMCs - Biologics | 3 |
| 5572 | Vaccines: RA and QA Aspects | 3 |
| Select at least one of the following: | 3 | |
5471 | Biotechnology: Bioprocess Basic | |
8005 | Pharmaceutical Biotechnology | |
5451 | Statistical Quality Control | |
5468 | Validation of FUE (Facilities, Utilities and Equipment | |
5474 | Process Validation | |
5479 | Advanced Good Manufacturing Practices - Defining “c” | |
5492 | Production of Sterile Products | |
5493 | Sterilization Processes | |
5501 | Development of Sterile Products | |
5512 | Microbiological Concepts in Pharmaceutical Manufacturing | |
5514 | Regulatory eSubmissions | |
5516 | Cleaning Validation | |
5538 | Clinical Drug Safety and Pharmacovigilance | |
5444 | Regulatory Intelligence | |
5571 | Post-Marketing Safety Surveillance | |
5574 | Quality Systems Management | |
5575 | Regulatory Sciences: Managing the Guidelines for Quality | |
5625 | Process Analytical Technology (PAT) | |
56 | Statistical Design of Experiments (DOE) | |
5629 | Process Monitoring | |
| Total Credits | 28.5-30 | |