In this workshop, participants will be introduced to experiments and techniques used in the biopharmaceutical industry to prevent microbial contamination of products, and biochemical assays that test for identity, purity and potency of the drug substance and product. Microbiological QC activities will include endotoxin testing, molecular and biochemical approaches to microbe detection and identification, and environmental monitoring. Biochemical QC techniques will focus on monoclonal antibody drug substance analysis and include aggregate testing by HPLC analysis, identity and concentration determination by ELISA and purity determination by SDS PAGE. In both the microbiological and biochemical sessions, techniques ranging from basic activities through advanced laboratory exercises will be performed in order to accommodate all levels of course and program development of the participating instructors.


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