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B I O P R O C E S S TECHNICAL
Cleaning and Cleaning Validation
in Process Chromatography
Current Industry Practices and Future Prospects
Gail Sofer and Jonathan Yourkin
uring regulatory inspections,
manufacturers of
biopharmaceuticals and
Dbiological products often find
attention directed to cleaning and
cleaning validation of chromatography
resins and multiuse purification
systems. Chromatographic resins must
either be disposed of or sufficiently
cleaned to ensure reproducibility in
subsequent cycles. The dec
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