Advanced Biotherapeutics: Manufacturing and Regulatory Affairs MS

SCHOOL OF PHARMACY

About the Program

The MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) is a program arising from a partnership between Temple University’s School of Pharmacy and the Kanbar College of Design, Engineering & Commerce at Thomas Jefferson University. The program combines courses from Temple’s Regulatory Affairs and Quality Assurance (RAQA) graduate program with courses from the Jefferson Institute for Bioprocessing (JIB). Students may earn the ABMRA degree from either Temple University or Thomas Jefferson University, depending on their area of interest: biopharmaceutical manufacturing (JIB) or regulatory affairs and quality assurance (Temple).

The ABMRA degree addresses the career needs of individuals involved in the discovery and manufacture of large-molecule therapeutic agents, including cell and gene therapies (GCT), vaccines and personalized medicines. The demand and discovery of these therapeutic agents based on monoclonal antibody-based therapies and messenger-RA technology continue to burgeon, creating a national shortage of skilled and knowledgeable professionals familiar with the manufacturing processes and regulatory/quality requirements of these agents.

Temple’s ABMRA degree highlights the regulatory science practices and strategies as well as quality expectations involved in the development and manufacture of biopharmaceutical products. Jefferson’s ABMRA degree focuses more on the development, manufacturing and analytical processes associated with the production of biopharmaceutical therapeutic agents on state-of-the-art equipment located at the JIB facility in Spring House, PA. Students have the ability to earn certificates from either school while also earning a degree from either Temple or Jefferson, depending on their preferred area of focus.

Graduates of the ABMRA degree from either university have a broad foundation in:

  • U.S. and global regulatory landscapes for biologics and biosimilars;
  • regulatory strategies for non-clinical and clinical studies for biologics and biosimilar products;
  • Chemistry, Manufacturing and Control (CMC) strategies for biologics and biosimilars;
  • phase-appropriate regulatory compliance elements applicable to biologics and biosimilars;
  • fundamentals of Quality by Design (QbD) and Statistical Process Control (SPC) principles as relevant to biologics and biosimilars manufacturing;
  • mastery of core engineering, scientific, regulatory and quality principles utilized in the development and manufacturing of biopharmaceuticals, biologics and advanced therapies;
  • biopharmaceutical manufacturing operations, including bioreactor, chromatography, formulation and product concentration operations; and
  • process development concepts, from early to late phase development and launch.

Time Limit for Degree Completion: 5 years

Campus Location: Online, in a hybrid format with some in-person instruction but the majority of learning online, or:

  • at Fort Washington evenings and weekends for Temple courses
  • at Spring House, PA for JIB courses

Full-Time/Part-Time Status: The degree program can be completed on a full- or part-time basis.

Interdisciplinary Study: The program fosters interdisciplinary study between biopharmaceutical sciences and technology as well as mandated regulatory and quality requirements.

Job Prospects: The program prepares graduates for positions in the global marketplace related to biosimilars and biologics.

Non-Matriculated Student Policy: Non-matriculated students are able to take up to 9 credits before formal application must be made to the program.

Financing Opportunities: Master's students are generally not considered for financial support.

Admission Requirements and Deadlines

Application Deadline:

Fall: March 1; December 15 international
Spring: November 1; September 1 international
Summer I: March 1; January 15 international

Applications are processed throughout the year. Late applications may be considered for admission. However, the entire application packet must be received by the Regulatory Affairs and Quality Assurance Office before it is reviewed by the Admissions Committee. Applicants are responsible for making sure that all materials have been received.

APPLY to this graduate program, submitting the application to QARA2@temple.edu. For more information, visit https://www.temple.edu/pharmacy_qara/applyingtoMS.html.

Students who wish to apply to Jefferson’s ABMRA MS should visit https://www.jefferson.edu/admissions/graduate/apply.html.

Letters of Reference:
Number Required: 2

From Whom: One letters of recommendation should be obtained from a college/university faculty member familiar with academic competence and one from a work supervisor.

Coursework Required for Admission Consideration: It is expected that applicants have a strong science or engineering background.

Bachelor's Degree in Discipline/Related Discipline: A BS in Bioengineering or Chemical Engineering, Biochemistry, Biology, Chemistry, Physics or a related discipline is required.

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).

Statement of Goals: Describe your experience in the pharmaceutical, biopharmaceutical or related industries, indicating how the ABMRA MS program will help you achieve your career objectives.

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
  • IELTS Academic: 6.5
  • PTE Academic: 58

Resume: Current resume or CV, signed by the applicant, required.

Transfer Credit: Transfer credits are not accepted. Any student who has completed a similar RAQA course through an accredited graduate program may request to replace a required course with a listed elective course. Such requests are considered on a case-by-case basis.

Program Requirements

General Program Requirements:
Number of Credits Required Beyond the Baccalaureate: 36, of which 21 are completed at Temple University's School of Pharmacy and 15 at Thomas Jefferson University's Jefferson Institute for Bioprocessing (JIB)

Required Courses:

Core Courses
QARA 5459Drug Development3
QARA 5515Biologics/Biosimilars: A Regulatory Overview3
QARA 5572Vaccines: Regulatory Affairs and Quality Assurance Issues3
QARA 5577Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics3
Electives
Select three from the following:9
Development of Sterile Products
Pharmaceutical Biotechnology
Statistical Quality Control
Validation of Facilities, Utilities and Equipment (FUE)
Biotechnology: Bioprocess Basics
Process Validation
Advanced Good Manufacturing Practices - Defining "c"
Production of Sterile Parenterals
Sterilization Processes
Microbiological Concepts in Pharmaceutical Manufacturing
Regulatory Electronic Submissions
Cleaning Validation
Clinical Drug Safety and Pharmacovigilance 1
Regulatory Intelligence
Post-Marketing Safety Surveillance 1
Pharmaceutical Quality Management Systems
Regulatory Sciences: Managing the Guidelines to Quality
Process Analytical Technology (PAT)
Statistical Design of Experiments (DOE)
Process Monitoring
JIB Required Courses 212
JIB Elective(s) 33
Total Credit Hours36

Culminating Events: This program has no culminating events beyond completion of coursework.

Contacts

Program Web Address:

https://pharmacy.temple.edu/raqa

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Submission Address for Application Materials:

QARA2@temple.edu

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Assistant Dean

qara@temple.edu

267-468-8560

Graduate Chairperson:

Swati Nagar, PhD

phscgrad@temple.edu

Assistant Dean:

Wendy Lebing, MALD, MS

wlebing@temple.edu

267-468-8560