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).
乐购彩票能赚钱吗• "... during the harvest of the unprocessed bulk, sublots of lot xxxx and lot yyyy exceeded the established action limits for bioburden."[...]