The ABMRA degree unites the strengths of two prestigious regional academic institutions. 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.

Students must complete a minimum of 15 credits in biopharmaceutical manufacturing from Thomas Jefferson University, including the following required courses:

• ENGR 609 – Bioprocess Engineering for Scientists (3 cr)
• ENGR 621 – Introduction to Biopharmaceutical and Biologics Production (3 cr)
• ENGR 611 – Principles of Biopharmaceutical Process Engineering (3 cr)
• ENGR 604 – Biopharmaceutical Process operations (3 cr)

Students may then choose at least one (1) course from the following list of electives:

• ENGR 601 – Introduction to Upstream Unit Operations: Cell Culture and Harvesting (3 cr)
• ENGR 602 – Introduction to Downstream Unit Operations: Purification, Buffer Exchange and Concentration (3 cr)
• ENGR 613 – Vector and Cell Line Design (3 cr)
• ENGR 622 – Biotherapeutic Formulation (3 cr)
• ENGR 614 – Vaccine Formulation (3 cr)
• ENGR 618 – Technical and Regulatory Aspects of Analytical Method Validation (1.5 cr)
• ENGR 612 – Emerging Therapeutics (1.5 cr)

Students must also complete five (5) Temple University RAQA courses (totaling 15 credits), including the following required courses:

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

Students may then choose at least one (1) course from the following list of electives:

• Biotechnology: Bioprocess Basics (5471) – 3 cr
• Pharmaceutical Biotechnology (8005) – 3 cr
• Statistical Quality Control (5451) – 3 cr
• Validation of FUE (Facilities, Utilities and Equipment) (5468) – 3 cr
• Process Validation (5474) – 3 cr
• Advanced Good Manufacturing Practices – Defining “c” (5479) – 3 cr
• Production of Sterile Products (5492) – 3 cr
• Sterilization Processes (5493) – 3 cr
• Development of Sterile Products (5501) – 3 cr
• Microbiological Concepts in Pharmaceutical Manufacturing (5512) – 3 cr
• Regulatory eSubmissions (5514) – 3 cr
• Cleaning Validation (5516) – 3 cr
• Clinical Drug Safety and Pharmacovigilance (5538*) – 3 cr
• Regulatory Intelligence (5544) – 3 cr
• Post-Marketing Safety Surveillance (5571*) – 3 cr
• Quality Systems Management (5574) – 3 cr
• Regulatory Sciences: Managing the Guidelines for Quality (5575) – 3 cr 
• Process Analytical Technology (PAT) (5625) – 3 cr
• Statistical Design of Experiments (DOE) (5627) – 3 cr
• Process Monitoring (5629) – 3 cr

*Students may enroll in one of these courses, but not both.