2024-2025 Academic Catalog 
    
    Jul 12, 2025  
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2024-2025 Academic Catalog [ARCHIVED CATALOG]

BIOT 2210 - Introduction to Good Laboratory Practices (GLP)

The course will focus on the use of cell culture produced biological proteins in the assembly of in vitro diagnostic (IVD) kit, such as an ELISA assay for 510K filing with the FDA.  The concepts of sterility, purification, assay development of a final product, creation of a Good Laboratory Practices (GLP) laboratory and the documentation of its operation & application will be discussed.  There will be key emphases on GLP operation and designing all laboratory techniques to follow regulations from WHO and FDA.  The course will require analysis of the assay design, production of assay data, and extensive writing on Standard Operating Procedures (SOP) to govern the GLP environment. 

Prerequisites: BIOT 1200 - Business Operations Management for Biotechnology  

Anticipated Terms Offered: spring
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