Research ArticleResearch
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 and Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 472-477; DOI: https://doi.org/10.5731/pdajpst.2014.00999
Jay S. Bolden
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
Mark E. Claerbout
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
Matthew K. Miner
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
Marie A. Murphy
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
Kelly R. Smith
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
Rob E. Warburton
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN

References
- 1.↵
Chapter <85> Bacterial Endotoxins Test. In United States Pharmacopeia; United States Pharmacopeial Convention: Rockville, MD, 2013.
- 2.↵
Chapter 2.6.14 Bacterial Endotoxins. In European Pharmacopoeia; The European Directorate for the Quality of Medicines & Health Care: Strasbourg, France, 2014.
- 3.↵
Chapter 4.01 Bacterial Endotoxins Test. In Japanese Pharmacopoeia; Japanese Ministry of Health, Labour and Welfare: Tokyo, Japan, 2011.
- 4.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry—Pyrogen and Endotoxin Testing: Questions and Answers, June 2012.
- 5.↵
- Chen J.
- 6.
- Bowers K.,
- Tran L.
- 7.↵
- Williams K.
- 8.↵
- McCullough K.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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, Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 472-477; DOI: 10.5731/pdajpst.2014.00999
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, Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 472-477; DOI: 10.5731/pdajpst.2014.00999
Jump to section
Related Articles
- No related articles found.