Program Requirements
General Program Requirements:
Number of Credits Required Beyond the Baccalaureate: 36, of which 21 are completed at 51¶¯Âþ's School of Pharmacy and 15 at Thomas Jefferson University's Jefferson Institute for Bioprocessing (JIB)
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| ²Ï´¡¸é´¡Ìý5459 | Drug Development | 3 |
| ²Ï´¡¸é´¡Ìý5515 | Biologics/Biosimilars: A Regulatory Overview | 3 |
| ²Ï´¡¸é´¡Ìý5572 | Vaccines: Regulatory Affairs and Quality Assurance Issues | 3 |
| ²Ï´¡¸é´¡Ìý5577 | Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics | 3 |
| Electives | ||
| Select three from the following: | 9 | |
±Ê³§Ìý5501 | Development of Sterile Products | |
±Ê³§Ìý8005 | Pharmaceutical Biotechnology | |
²Ï´¡¸é´¡Ìý5451 | Statistical Quality Control | |
²Ï´¡¸é´¡Ìý5468 | Validation of Facilities, Utilities and Equipment (FUE) | |
²Ï´¡¸é´¡Ìý5471 | Biotechnology: Bioprocess Basics | |
²Ï´¡¸é´¡Ìý5474 | Process Validation | |
²Ï´¡¸é´¡Ìý5479 | Advanced Good Manufacturing Practices - Defining "c" | |
²Ï´¡¸é´¡Ìý5492 | Production of Sterile Parenterals | |
²Ï´¡¸é´¡Ìý5493 | Sterilization Processes | |
²Ï´¡¸é´¡Ìý5512 | Microbiological Concepts in Pharmaceutical Manufacturing | |
²Ï´¡¸é´¡Ìý5514 | Regulatory eSubmissions | |
²Ï´¡¸é´¡Ìý5516 | Cleaning Validation | |
²Ï´¡¸é´¡Ìý5538 | Clinical Drug Safety and Pharmacovigilance 1 | |
²Ï´¡¸é´¡Ìý5544 | Regulatory Intelligence | |
²Ï´¡¸é´¡Ìý5571 | Post-Marketing Safety Surveillance 1 | |
²Ï´¡¸é´¡Ìý5574 | Pharmaceutical Quality Management Systems | |
²Ï´¡¸é´¡Ìý5575 | Regulatory Sciences: Managing the Guidelines to Quality | |
²Ï´¡¸é´¡Ìý5625 | Process Analytical Technology (PAT) | |
²Ï´¡¸é´¡Ìý5627 | Statistical Design of Experiments (DOE) | |
²Ï´¡¸é´¡Ìý5629 | Process Monitoring | |
| JIB Required Courses 2 | 12 | |
| JIB Elective(s) 3 | 3 | |
| Total Credit Hours | 36 | |
- 1
Students may take ²Ï´¡¸é´¡Ìý5538 or ²Ï´¡¸é´¡Ìý5571, but not both.
- 2
Four 3-credit courses required by JIB include ENGR 604 Biopharm Process Operations, ENGR 609 Bioprocess Engineering for Scientists, ENGR 611 Principles of Biopharmaceutical Process Engineering, and ENGR 621 Introduction to Biopharmaceutical and Biologics Production. Coursework is subject to change to reflect the most current trends and techniques in the production of biopharmaceutical therapeutic agents.
- 3
Electives approved by JIB include four 3-credit courses: ENGR 601 Intro Upstream Unit Operations, ENGR 602 Intro Downstream Unit Operations, ENGR 613 Vector and Cell Line Design, and ENGR 622 Biotherapeutic Formulation. Three 1.5-credit courses are also approved: ENGR 612 Emerging Therapeutics; ENGR 614 Vaccine Formulation; and ENGR 618 Technical and Regulatory Aspects of Analytical Method Validation. Coursework is subject to change to reflect the most current trends and techniques in the production of biopharmaceutical therapeutic agents.
Culminating Event: Successful completion of coursework is required to earn 51¶¯Âþ’s ABMRA MS.