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Kevin L Williams

 

Specificity in the recombinant factor C test for endotoxin

Limulus amebocyte lysate (LAL) users, compendial experts and regulators are…

26 April 2018 | By

Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .

Microbiology In-Depth Focus 2017

The European Pharmacopoeia chapter on methods for microbiological quality control…

19 October 2017 | By

The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.

A paradigm change in biologics microbiological contaminant control

Contaminant detection methods derived from the innate, proinflammatory responses of…

17 October 2017 | By

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...

Microbiology In-Depth Focus 2017

In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance…

13 April 2017 | By

In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...

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