Kevin L Williams

Application note: Industry pushes back on USP draft chapter

15 February 2021 | By Kevin L Williams

Outlining the most common comments from drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA) on the USP draft chapter for recombinant Factor C ().

article

A paradigm change in biologics microbiological contaminant control

17 October 2017 | By Kevin L Williams

Contaminant detection methods derived from the innate, proinflammatory responses of rabbits and Limulus blood have been used to determine the existence of microbial artefacts in small-molecule drugs (SMDs) and large-volume parenterals (LVPs) for decades...

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Kevin L Williams

Application note: Industry pushes back on USP draft chapter

A paradigm change in biologics microbiological contaminant control