BIOT2200

Description

Section information text: This course will provide practical examples exposing students to the establishment of GLP and GMP guidelines, critical for the bio-manufacturing of pharmaceutical products worldwide. The course will focus on the application of GLP and GMP principles to establish facilities with the proper heating, ventilation, containment and disposal requirement for bio-manufacturing. The concepts of sterility, purification, assay development, analytical testing, electronic documentation and extensive auditing will be discussed. There will be key emphases on GLP and GMP design and operation to follow all the relevant regulations from WHO and FDA. Furthermore, the course will discuss the sourcing and inventory of ingredients important for small molecules, protein products and cell products manufacturing. The subsequent process and product development (upstream/downstream) under analytical testing will be explained so that students will have a realistic picture of a bio-manufacturing process under a regulated and traceable environment.