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Chapter 8 Microbiological Control - Biomanufacturing

2016 Montgomery County Community College Chapter 8 Microbiological Control 282 Chapter 8 - Microbiological Control Objectives This Chapter provides an overview of Microbiological Control in the Biomanufacturing industry. After completing this Chapter the student will be able to: Explain why Microbiological Control is important in a Biomanufacturing facility and provide a number of examples as to how it is achieved and maintained. Describe the various sources of microbial contamination within a Biomanufacturing facility/process and name specific microbial contaminants and their possible sources. Explain the different Microbiological cleanliness standards required for the manufacture of biopharmaceutical drug substances and drug products.

Concerning the former, certain bacteria and molds secrete proteolytic enzymes into the growth medium, potentially degrading the therapeutic protein. Regarding the latter, Gram-negative bacteria release a component of their cell wall termed endotoxin that can be highly toxic if introduced into patients. It is one example of a pyrogen. Pyrogens ...

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  Control, Microbiological, Enzymes, Control microbiological, Degrading

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