A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics, large-scale Production of .. Read more Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance manufacture, or Drug Product manufacture they occur, microbial contaminations can have a significant impact on product quality and patient safety.
Dr Friedrich von WintzingerodeQC Lead iNeST Project
Shabnam SolatiCEO & Co-Founder
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