For biopharmaceutical process development and process characterization, bioprocess scale down model qualification is a highly debated topic. A new EMA paper on comparability testing now provides new insights on current …
Read more...Process characterization is an essential step in the commercialization of a new (biological-) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures, that the manufacuring …
Read more...You develop, optimize and characterize bioprocesses in laboratory scale. Yet, you expect that the insights from laboratory scale do not change during scale-up. Hence, your laboratory results are representative and …
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