Kevin L. Williams

Endotoxin Test Concerns of Biologics Part II: Developing New Tools
Monday, March 31, 2014
Bacterial Endotoxin Test (BET) users seek ways to overcome low endotoxin recovery (LER) from direct spikes into undiluted biologics. These studies have come about from Chen’s initial observation1 that Control Standard ... read more
Endotoxin Test Concerns of Biologics
Monday, October 28, 2013
Limulus Amoebocyte Lysate (LAL) users are exploring regimens to study the effects of adding endotoxin to undiluted biologics in reaction to Chen’s studies (Genentech) on Low Endotoxin Recovery (LER) [1] and, moreover, in ... read more
Ancient and Modern Endotoxin Biosensors: Evolutionary Perspectives Inform LAL Technologies
Saturday, August 31, 2013
Since the inception of Limulus amebocyte lysate (LAL) testing [1], the past four decades of testing have proven fruitful in terms of making in-vitro predictions of in vivo responses regarding the significant pyrogen of drug ... read more
The BET as a Backdrop for Establishing PAT and RMM Goals
Tuesday, December 01, 2009
FDA has defined Process Analytical Technology (PAT) as “Systems for analysis and control of manufacturing processes based on timely measurements during processing, of critical quality parameters and performance attributes of ... read more

Articles by Kevin L. Williams