Biopharmaceutical Manufacturing and Regulatory Affairs Certificate

Students have the option to complete a post-master’s curriculum in biopharmaceutical manufacturing and regulatory affairs in Temple’s School of Pharmacy, offered through the school’s RA and QA graduate program. 

This post-master’s certificate requires the completion of coursework focusing 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. 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. 

Learning Objectives

Upon completion of the post-master's certificate, students will understand the

• pharmaceutical science behind the discovery of biotechnology products, including biologics, biosimilars and biopharmaceuticals;

• requirements for sourcing and testing materials used in the production of biotechnology products;

• technologies and unique considerations associated with the manufacturing and distribution of biotechnology products;

• applicable regulations involved with biotechnology products; and

• processes used to sterilize biotechnology products, including regulatory requirements for thermal, gaseous, radiation, filtration and aseptic processing.