MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs

College

Kanbar College of Design, Engineering & Commerce

Degree

Master of Science

Campus

East Falls

Format

Hybrid (Online and On Campus)

Enrollment Options

Part Time

Curriculum

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.