Biologics and Biosimilars: Manufacturing Certificate

The Certificate in Biologics and Biosimilars: Manufacturing in the School of Pharmacy at Temple University focuses on chemistry, manufacturing and control (CMC) aspects in the development and manufacture of biopharmaceutical products, preparing students for positions in the industry and sharpening the skills and knowledge of those already working in this field. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program and is available online. A master’s degree is not required to earn this certificate.

The first biopharmaceutical product (recombinant human insulin) was approved in 1982, and since then, 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. 

The Biologics and Biosimilars: Manufacturing 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. Faculty are drawn from the Food and Drug Administration (FDA) and the biopharmaceutical industry, ensuring that the latest developments and practices are taught. They are industry veterans with years of expertise in their specialties, who share their considerable knowledge with students through classroom discussions and hands-on workshops.  

Students who complete the Certificate in Biologics and Biosimilars: Manufacturing sharpen their knowledge of this industry niche without committing to the entire master’s degree. Executive recruiters often seek candidates with demonstrated knowledge of the application of regulations to biologics and biosimilar manufacturing. The certificate provides students with credentials from Temple’s well-respected RA and QA graduate program, giving them a solid grounding in the issues surrounding biopharmaceutical manufacturing. The certificate is open to both MS applicants and graduates, who can expand their career opportunities with this new credential.

Learning Objectives 

Upon completion of the certificate, students will understand 

  • CMC strategies for biologics and biosimilars at a deeper level; 

  • phase appropriate regulatory compliance elements applicable to biologics and biosimilars manufacturing; 

  • major steps involved in the manufacture of biologics and biosimilars;  

  • fundamentals of quality by design (QbD) as relevant to biologics and biosimilars manufacturing; and

  • fundamentals of statistical process control principles as relevant to biologics and biosimilars manufacture.  

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in biologics and biosimilars manufacturing. This post-master’s certificate requires the completion of coursework focusing on how biologics and biosimilars are manufactured, looking specifically at regulatory compliance elements, fundamentals of QbD and statistical process control. 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 biology, chemistry, engineering, pharmacy, physics or related fields.

Learn more about the Post-master’s Certificate in Biologics and Biosimilars: Manufacturing.

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards.

The School of Pharmacy  

  • pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum;   

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

Certificates provide credentials from Temple’s well-respected RA and QA graduate program, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum  

It is strongly suggested that students have a bachelor’s degree in biology, chemistry, engineering, pharmacy, physics or related fields from an accredited institution of higher learning. However, a degree in the sciences is not required.

The Certificate in Biologics and Biosimilars: Manufacturing may be earned on its own or on the way to the RA and QA MS or the Advanced Biotherapeutics: Manufacturing and Regulatory Affairs MS, offered in partnership between Temple University’s School of Pharmacy and the Kanbar College of Design, Engineering and Commerce at Thomas Jefferson University. To earn the certificate, five courses must be completed within a four-year period with an overall B (3.0) average. 

Students must complete the following four required courses. 

  • Biotechnology: Bioprocess Basics (RAQA 5471): Students with prior educational or biologics manufacturing experience may substitute a course from the elective list below in lieu of this course. 

  • Biologics/Biosimilars: A Regulatory Overview (RAQA 5515): Students with prior educational or biologics regulatory experience may substitute a course from the elective list below in lieu of this course. 

  • Global CMCs—Biopharmaceuticals and Other Biologics (RAQA 5577) 

  • Pharmaceutical Biotechnology (8005) 

Students must also complete one elective from the following courses. 

  • 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 54 79) 
  • 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) ​

All courses must be completed from Temple University’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. 

Learn more about the Biologics and Biosimilars: Manufacturing Certificate.

See the curriculum. 

Requirements 

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

  • Only one certificate program may be completed before students receive the MS.

  • Students must complete the certificate within four years, and courses may be completed online. Students must apply for the certificate within one year of completing all required coursework for the program. 

  • Students interested in pursuing the RA and QA MS degree may apply all credits earned in the certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates at Temple University are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full Cost of Attendance breakdown on the Student Financial Services website. You can also view the the tuition rates for the 2024–2025 academic year. 

Accreditation

Temple University’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-BBMN-GRAD

Additional Program Information

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