Biologics and Biosimilars: Manufacturing Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in biologics and biosimilars manufacturing 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 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. 

Learning Objectives

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

• 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 manufacturing of biologics and biosimilars; 

• fundamentals of QbD as relevant to biologics and biosimilars manufacturing; and

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