Beyond USP <86>:  Supplemental Testing

USP <86>, “Bacterial Endotoxins Test Using Recombinant Reagents” states, “Regulatory authorities may require supplemental data prior to acceptance…An example of supplemental data may include a comparative study of the material tested by techniques described in this chapter and those in 〈85.”  The term “supplemental data” may refer to the use of a statistically robust analysis of test results obtained from a single sample containing assayable levels of endotoxins activity, using both the predicate assay (<85>) and the candidate recombinant assay (<86>).

This webinar discusses the difference between 50-200% acceptance testing and statistical equivalence.  In addition, using data in the public domain as examples, the speakers will stress the importance of using a split sample containing assayable levels of contaminating or potentially contaminating endotoxins activity as the test article for these studies. 

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates

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 speciality 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 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.

John Duguid, Executive Director, Research & Development at Vericel Corporation

John Duguid is the Executive Director of Research and Development at Vericel, where he is the CMC technical lead for commercial-stage autologous cell therapy products. Previously a Principal Scientist at Genzyme, Mr Duguid was responsible for developing and implementing rapid microbiological methods and had also managed QC operations. Prior to Genzyme, he worked as an analytical chemist at Abbott Laboratories and Arthur D. Little. Mr. Duguid received his BS in Chemistry from the University of Michigan

Steven Walfish, Principal Consultant at Statistical Outsourcing Services

Mr. Walfish is the Principal Consultant at Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Mr. Walfish has held roles at United States Pharmacopeia (USP) as Principal Statistician at Becton Dickinson in Franklin Lakes, NJ, responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification, validation, and stability analysis. Mr. Walfish holds a Bachelor of Arts in Statistics from the University of Buffalo, a Masters of Science in Statistics from Rutgers University, and an Executive MBA from Boston University.