51¶¯Âþ

Biopharmaceutical Manufacturing and Regulatory Affairs Certificate 

The Biopharmaceutical Manufacturing and Regulatory Affairs Certificate in the at 51¶¯Âþ focuses on the complex regulations governing the development, manufacture and distribution of these products, preparing students for positions in biotechnology and sharpening the skills and knowledge of those already working in this field.ÌýThis certificate is part of the School of Pharmacy’s .Ìý

All courses in the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate are offered online, allowing remote students to participate in this highly relevant program.Ìý

What is biopharmaceutical manufacturing?

Biopharmaceutical manufacturing uses biotechnology to develop and produce medical therapies, also known as biologics, and diagnostic processes. Ever since the first biopharmaceutical product (recombinant human insulin) was approved in 1982, products derived through biotechnology have provided medical advances that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA and growth factors.

Why study biopharmaceutical manufacturing in the RAQA graduate program at 51¶¯Âþ?  

The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. This five-course certificate presents a strong regulatory focus, enabling students to become fluent in the most current regulations and trends affecting the industry.

Learning Outcomes

• Current pharmaceutical science methods used in the discovery of biotechnology products in biopharma manufacturing, including materials sourcing and testing requirements.
• Technologies and unique considerations associated with the manufacturing and distribution of biotechnology products.
• Biotechnology regulatory affairs, such as the regulatory requirements for sterilization processes.Ìý

Career Opportunities

The biotechnology industry continues to offer new job opportunities in the U.S. and abroad. The two largest U.S. hubs for biotechnology are Boston and San Francisco, accounting for over 50,000 jobs in pharmaceutical biotechnology discovery and development. Hundreds of small, startup biotechnology companies exist throughout the U.S.Ìý

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in Biopharmaceutical Manufacturing and Regulatory Affairs. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biochemistry, biology, chemistry, physics or a health-related discipline.

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Program Format & Curriculum

The Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate is only available on a part-time basis, giving you the flexibility to take classes while working full time. Classes take place online and in-person at 51¶¯Âþ’s Fort Washington campus, which is only 20 miles from 51¶¯Âþ’s Main Campus.

Students will have three years to complete four required courses and one elective.

There are four required courses.

• Pharmaceutical Biotechnology (8005)
• Biotechnology: Bioprocess Basics (5471)
• CMCs–Biologics (5577)
• Biologics/Biosimilars: A Regulatory Overview (5515)

Students can then complete one of the following elective courses.

• 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)

All courses must be completed from 51¶¯Âþ’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate.Ìý

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• Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).Ìý 

• Matriculated students may earn the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate as they complete the MS in RA and QA.Ìý 

• The certificate must be completed within four years. Students must apply for the certificate no more than one year after completing the course requirements.Ìý

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS