2024-2025 Academic Catalog 
    
    Jul 13, 2025  
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2024-2025 Academic Catalog [ARCHIVED CATALOG]

BIOT 2220 - Introduction to Good Manufacturing Practices (GMP)

This course offers practical examples to the application of GMP guidelines, critical for the bio-manufacturing of pharmaceutical products worldwide.  The course will focus on the establishment of facilities with the proper heating, ventilation, containment and disposal requirement for bio-manufacturing under GMP.  The concepts of sterility, purification, assay development, analytical testing, electronic documentation and extensive auditing will be discussed.  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.

Prerequisites: BIOT 1200 - Business Operations Management for Biotechnology  

Anticipated Terms Offered: spring
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