USP Open Forum on Alternatives to Compendial Reagents used in the Bacterial Endotoxins Test

Agenda

The U.S. Pharmacopeia (USP) held an open forum on bacterial endotoxin testing (BET) on November 15th and 16th to continue stakeholder engagement with representatives from industry, academia, regulatory bodies, and others.  Stakeholder input is an important aspect of USP’s standards development and revision process.

For information about USP standard on General Chapter <1085.1> Validation Of Alternative Methods to The Bacterial Endotoxins Test, please contact Leslie Furr, Ph.D., Senior Scientist II, Science-General Chapters at leslie.furr@USP.org.

Event Presentations
Day One:

  1. Setting the Stage: <1085.1> Science and Stakeholders; Karen McCullough, Subcommittee Chair, Endotoxins and Pyrogens | USP
  2. Pfizer Study Comparing Endotoxin Test Methods on Biopharmaceutical Water Samples; Ned Mozier, Ph.D., Vice President | Pfizer
  3. Comparability Testing of Recombinant Cascade Reagents as Kinetic Chromogenic Reagents against Traditional LAL Reagents; Veronika Wills, M.Sc., Manager of Technical Services | Associated of Cape Cod
  4. Endotoxin Testing of About 40 Different Autochthonous and Common Water Contaminating Microorganisms – an LAL and rfc Comparative Study; Christian Faderl, Ph.D., Project Coordinator Endotoxin and Kevin Williams, Senior Scientist | bioMerieux
  5. The Importance of Data Comparability of LAL and Recombinant Endotoxin Testing Methods with Naturally Contaminated Products; Nicola Reid, Associate Director of Product Management and John Dubczak, Executive Director of Reagent Development & Pilot Plant Operations | Charles River

Day Two:

  1. Effect of Formulation on Recovery of Natural Endotoxins; Masakazu Tsuchiya, Ph.D., Senior Research Scientist, and Foster Jordan, Corporate Senior Vice President of Microbial Solutions | Charles River
  2. Use of an Autochthonous Endotoxin Spike from Upstream Water to Simulate a Process Breach in Four Representative Parenteral Products; Allen Burgenson, Testing Solutions Global SME | Lonza
  3. FDA Perspective on Recombinant Endotoxins Detection Systems; Reyes Candau-Chacon, Ph.D.  l U.S. FDA
Virtual Meeting