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Key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.
Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).
This page provides an overview of USP <87>, <88>, and <1031>, compares bioreactivity testing, and describes the transition of our organization towards in vitro test methods.
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