Biopharmaceutical Manufacturing and RA (Biotechnology)
Available at the the Pre- and Post-Master's Levels
Pre-Master's Certificate in Biopharmaceutical Manufacturing and RA (Biotechnology)
The first biopharmaceutical product (recombinant human insulin) was approved in 1982. Since then, products derived through pharmaceutical biotechnology have provided medical advances that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous, and highly complicated. The Pharmaceutical Manufacturing and RA Certificate delves into the complex regulations governing the development, manufacturing, and distribution of such products.
Required courses:
- Pharmaceutical Biotechnology (8005)
- Biotechnology: Bioprocess Basics (5471)
- CMCs - Biologics (5577)
- Biologics/Biosimilars: A Regulatory Overview (5515)
One elective from:
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Vaccines: RA and QA Issues (5572)
- Regulatory Bioanalysis (5621)
Brochure
Application
Notice of Completion
Post-Master's Certificate in Biopharmaceutical Manufacturing and RA (Biotechnology)
Graduates of our MS in RAQA degree are welcome to complete the Post-Master’s Certificate in Biopharmaceutical Manufacturing and Regulatory Affairs.
Four courses beyond the MS are required to receive this Certificate. One of the courses must be Pharmaceutical Biotechnology (8005). If this course was already completed as part of the MS, the student may substitute another course from the list of accepted courses below. Courses taken for the completion of the MS degree will not be counted. Students must apply for the Certificate before taking any courses.
These courses must be taken towards completion of the program:
- Biotechnology: Bioprocess Basics (5471)*
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)*
- Biologics/ Biosimilars: A Regulatory Overview (5515)*
- Vaccines: RA and QA Issues (5572)
- Regulatory Bioanalysis (5621)
- Pharmaceutical Biotechnology (8005)*
*These courses must be completed as part of the certificate. If students previously took them as part of the MS in RAQA, they may select other courses on this list.
Transfer credits are not accepted towards Temple’s certificate programs. Students may receive more than one post-master's certificate.
Master’s Students from Other Accredited Schools in the U.S.
If you did not receive the MS in RAQA from Temple University, you are required to complete five approved courses to receive the Post Master's Certificate in Biopharmaceutical Manufacturing and RA. Please refer to the Brochure regarding course choices. You must have sufficient industry experience and demonstrated familiarity with basic tenets of RAQA to pursue the Temple U Post Master's Certificate in Biopharmaceutical Manufacturing and RA. You must apply and be accepted into the Post-Master's Certificate program before registering for any courses.