ENDOTOXINS - Mechanisms of hidden endotoxin in biologics manufacturing
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."[...]