James Cooper, PharmD
Consultant and Founder of Endosafe Inc.
Dr. Cooper, PharmD, was an innovator of the bacterial endotoxins test (BET) for parenteral products. His publications span the history of LAL (Limulus amebocyte lysate) technology. He set up the FDA's LAL program at Biologics in 1972. In 1987 he founded Endosafe, an LAL production unit, that is now part of Charles River Labs. Now retired, he continues to publish and consult on horseshoe crab conservation, depyrogenation, BET methods, endotoxin issues and root-cause investigations. He served on the Council of Experts for the USP's Sterile Compounding Committee. He received his Doctor of Pharmacy from the University of Tennessee. He completed his M.S. at The John Hopkins University where he collaborated with Dr. Jack Levin on early LAL innovation and application to parenterals. He taught the endotoxin component of the PDA's Aseptic Processing course and was honored with the Agalloco Award for Excellence in Education. He is Professor Emeritus of Pharmaceutical Sciences at the Medical University of South Carolina.