MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs

The Advanced Biotherapeutics: Manufacturing & Regulatory Affairs (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 credits)
• ENGR 621 – Introduction to Biopharmaceutical and Biologics Production (3 credits)
• ENGR 611 – Principles of Biopharmaceutical Process Engineering (3 credits)
• ENGR 604 – Biopharmaceutical Process Operations (3 credits)

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

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

• Drug Development (5459) (3 Credits)
• Biologics / Biosimilars: A Regulatory Overview (5515) (3 Credits)
• Global CMCs – Biologics (5577) (3 Credits)
• Vaccines: RA and QA Aspects (5572) (3 Credits)

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

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

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