Ever since the first biopharmaceutical product (recombinant human insulin) was approved in 1982, products derived through biotechnology have provided medical advances that include cell and gene therapies, therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors.
Temple's Certificate in Biologics and Biosimilars Manufacturing focuses on CMC aspects in the development and manufacture of these products, preparing students for positions in the biopharmaceutical industry and sharpening the skills and knowledge of those already working in this field.
This five-course certificate enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed.
Students must complete four required courses:
- Biotechnology: Bioprocess Basics (RAQA 5471)*
- Biologics/Biosimilars: A Regulatory Overview (RAQA 5515*
- Global CMCs – Biopharmaceuticals and Other Biologics (RAQA 5577)
- Pharmaceutical Biotechnology (8005)
And one elective from:
- Statistical Quality Control (RAQA 5451)
- Validation of FUE (Facilities, Utilities, and Equipment (RAQA 5468)
- Process Validation (RAQA 5474)
- Advanced Good Manufacturing Practices – Defining “c” (RAQA 5479)
- Production of Sterile Products (RAQA 5492)
- Sterilization Processes (RAQA 5493)
- Development of Sterile Products (RAQA 5501)
- Microbiological Concepts in Pharmaceutical Manufacturing (RAQA 5512)
- Cleaning Validation (RAQA 5516)
- Vaccines: RA and QA Issues (RAQA 5572)
- Statistical Design of Experiments (DOE) (RAQA 5627)
- Process Monitoring (RAQA 5629)
Students with prior educational or biologics manufacturing experience may substitute a course from the list above with written permission from the RAQA Office.
We offer two certificates in biologics and biosimilars. If you are looking for a program with a greater emphasis on regulatory aspects related to biologics and biosimilars, review our Certificate in Biologics and Biosimilars: Regulatory Aspects.
All courses may be completed online. The GRE is not required for the Biologics and Biosimilars Manufacturing Certificate. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.
Application Information for RAQA Pre-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Pre-Master's Certificates
- Call the RAQA office at 267-468-8560 to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Pre-Master's Certificates
- A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements.
- Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu