Jay S. Bolden

Results of a harmonized endotoxin recovery study protocol evaluation by 14 BioPhorum Operations Group (BPOG) member companies.

Jay S. Bolden, Michael Knight, Shahrzad Stockman, 2017, Biologicals : journal of the International Association of Biological Standardization.

Recombinant Factor C

Jay S. Bolden, 2019, Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems.

Endotoxin recovery using limulus amebocyte lysate (LAL) assay.

R. Warburton, Dayue Chen, Kelly R. Smith, 2016, Biologicals : journal of the International Association of Biological Standardization.

Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection

R. Warburton, Kelly R. Smith, Jay S. Bolden, 2014, PDA Journal of Pharmaceutical Science and Technology.

Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review

F. von Wintzingerode, J. Levin, N. Mozier, 2020, PDA Journal of Pharmaceutical Science and Technology.

Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products

Kelly R. Smith, Jay S. Bolden, 2017, PDA Journal of Pharmaceutical Science and Technology.

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing

Aditya Prasad, Lisa Yan, Philip Villari, 2018, PDA Journal of Pharmaceutical Science and Technology.

Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing

Jay S. Bolden, Marine Marius, Ingo Spreitzer, 2023, Alternatives to laboratory animals : ATLA.