Streamlining Process Validation for Drug Substance Manufacturing

Juergen Utz, Ph.D., Gerhard Noessner, Ph.D., and Juergen Bank, Ph.D., of Fareva Excella discuss how developing robust processes from the outset by building broad and fundamental process knowledge minimizes future validation and revalidation work for drug substance manufacturing.

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Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

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