Graduate Certificate: Biologics and Biosimilars Manufacturing

SCHOOL OF PHARMACY

About the Certificate

Given the rapidly expanded development of biopharmaceuticals in the past decade, an immediate need exists for professionals with knowledge of and credentials in key manufacturing quality issues governing biologics and biosimilar drugs. The graduate certificate in Biologics and Biosimilars Manufacturing requires the completion of coursework focusing on how biologics and biosimilars are manufactured, looking specifically at regulatory compliance elements, fundamentals of Quality by Design (QbD) and Statistical Process Control (SPC). Chemistry, Manufacturing and Controls (CMC) strategies, including materials sourcing and testing requirements, are also studied. Discussions include the technologies used in manufacturing and the unique considerations that arise when dealing with such technologies as cell and gene therapies, therapeutic monoclonal antibodies, vaccines, cytokines, antisense technology, interference RNA and growth factors.

Time Limit for Certificate Completion: 4 years, with courses meeting for a minimum of 36 class contact hours over 10 or 12 consecutive weeks

Campus Location: Fort Washington, with some in-person instruction but the majority of learning/instruction online

Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

APPLY HERE to the post-baccalaureate certificate program.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biology, Chemistry, Engineering, Pharmacy, Physics or related fields.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 15

Required Courses:

Core Courses
PS 8005Pharmaceutical Biotechnology3
QARA 5471Biotechnology: Bioprocess Basics 13
QARA 5515Biologics/Biosimilars: A Regulatory Overview 13
QARA 5577Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics3
Elective
Select one from the following:3
Development of Sterile Products
Special Topics in Regulatory Affairs and Quality Assurance 2
Statistical Quality Control
Validation of Facilities, Utilities and Equipment (FUE)
Process Validation
Advanced Good Manufacturing Practices - Defining "c"
Production of Sterile Parenterals
Sterilization Processes
Microbiological Concepts in Pharmaceutical Manufacturing
Cleaning Validation
Vaccines: Regulatory Affairs and Quality Assurance Issues
Statistical Design of Experiments (DOE)
Process Monitoring
Total Credit Hours15

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/programs-degrees-certificates/certificate-programs/pre-masters-certificates/biologics-and-biosimilars-manufacturing-certificate%C2%A0

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

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

Program Coordinator

qara@temple.edu

267-468-8560