Publications by authors named "Jay Bolden"

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It is time to reconsider the use of naturally-occurring endotoxins in endotoxin recovery studies: Part 2 of a BioPhorum harmonized endotoxin recovery study.
Jay Bolden, Michael Knight, Jordan Montz, Jeff One, Share Stockman

Biologicals· August 2024

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Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing.
Elizabeth Baker, Jessica Ponder, Johannes Oberdorfer, Ingo Spreitzer, Jay Bolden

Altern Lab Anim· November 2023

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Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review.
Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris

PDA J Pharm Sci Technol· August 2021

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Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Jay S Bolden

PDA J Pharm Sci Technol· May 2019

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Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products.
Jay Bolden, Kelly Smith

PDA J Pharm Sci Technol· June 2018

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Evidence against a bacterial endotoxin masking effect in biologic drug products by limulus amebocyte lysate detection.
Jay S Bolden, Mark E Claerbout, Matthew K Miner, Marie A Murphy, Kelly R Smith

PDA J Pharm Sci Technol· January 2018

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Results of a harmonized endotoxin recovery study protocol evaluation by 14 BioPhorum Operations Group (BPOG) member companies.
Jay Bolden, Michael Knight, Shahrzad Stockman, Bastian Omokoko

Biologicals· July 2017

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Endotoxin recovery using limulus amebocyte lysate (LAL) assay.
Jay S Bolden, Rob E Warburton, Robert Phelan, Marie Murphy, Kelly R Smith

Biologicals· September 2016

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