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ENDOTOXINS - Mechanisms of Hidden Endotoxin in Biologics Manufacturing

2017-PDA-MECHANISMS OF HIDDEN ENDOTOXIN IN BIOLOGICS MANUFACTURING.jpg

Endotoxin is an impurity from the expression system (if E. coli) or is a contaminant from Bioburden. People say: “But there is no Bioburden”

Bioburden concerns are cited after regulatory scrutiny:

• Multiple lots of DS released which had unacceptable high levels of bioburden during the final purification steps.

• No microbial limits are established for processing steps, and results show high bioburden levels (>1000 CFU/mL).

• "... during the harvest of the unprocessed bulk, sublots of Lot xxxx and Lot yyyy exceeded the established action limits for bioburden."[...]

 

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