Preview of USP’s Informational Chapter <1085>, “Guidelines on the Endotoxins Test”

11th June 2018 | 10 AM EST | Karen Zink McCullough & Kevin L. Williams |WATCH FOR FREE

The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge on LAL testing.  Some of these gaps include:  Guidance on RSE:CSE standardization, Guidance on Training, Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter <1085>, that will appear in the July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and more.  This seminar will provide an overview of the contents of this new informational chapter.

Presented by Karen Zink McCullough

Karen Zink McCullough is the principal consultant at MMI Associates, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy and medical device industries, with a specialty in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test:  A Practical Guide.”   She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University, and a Master’s degree in Molecular Biology from the University of Oregon.


Sponsored by BIOMÉRIEUX

Presented by Kevin L. Williams,  Senior Scientist Endotoxin – BIOMÉRIEUX USA, Inc.

Kevin studied microbiology at the Texas A&M University and has worked in the pharmaceutical field for 35 years. The bulk of his career was spent at Eli Lilly & Company (30 years) developing QC tests for microbial and endotoxin detection. Kevin‘s current role at bioMérieux as Senior Scientist focuses on endotoxin science and method development, and he has also helped setting up a dedicated endotoxin service laboratory in the USA. He is the author of: Endotoxins 2nd Edition (Marcel Dekker, 2001) and Endotoxins 3rd Edition (Informa Healthcare, 2007).


Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in 2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP chapters <1225> and <85>.


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