2021 PDA Endotoxins Workshop

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Program Highlights
Now fully virtual! This is the one endotoxins workshop you don’t want to miss. Best part of all is that you can attend from the comfort of your home or office wherever you are!

On behalf of the Program Planning Committee and PDA, we would like to invite you to the 2021 PDA Endotoxins Workshop on 07 October 2021. The agenda will focus on the theme of “Practical Insights into the Evolution of Endotoxin Testing”.

Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is evolving as well.

The 2021 PDA Endotoxins Workshop will provide scientific understanding and real-world practices for endotoxin testing in bio/pharmaceutical production processes.
Major topics to be covered will include:

  • Recombinant Reagent
  • Automation
  • Data Integrity
  • The Pyrogenic Dose, Specifications and Co-infusions
  • Regulatory Compendia

We look forward to seeing you at the 2021 PDA Endotoxins Workshop online!

Upon completion of this workshop, you will be able to:
  1. Understand complex interaction of endotoxins with immune system
  2. Identify the best test method for endotoxin analysis for your company’s purpose
  3. Select appropriate endotoxin specifications for your company’s products
  4. Describe best practices for your company’s new or existing laboratories

Standard Registration

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See Qualifying Criteria for Member Types.

Day 1

Thursday, 07 October

08:45 – 10:30 | Plenary 1: Recombinant Reagent
Moderator: Anders Thorn, M.Sc. Pharm, Principal Scientist, Microbial Competence Centre, Novo Nordisk A/S

Recombinant reagents for endotoxin detection has been available for many years as an alternate to LAL-based testing and it has been an official method for test for endotoxin in the European Pharmacopeia since January 2021 although comparison of the performance of recombinant reagents and LAL is still subject to discussion.
This session will discuss strategies for validation and for implementation of the recombinant reagents for endotoxins testing. Furthermore, studies that evaluates the use of recombinant technology for the detection of environmental endotoxin will be summarized.

Welcome from the Program Planning Committee Co-Chair

rFC Implementation Strategy for Endotoxin Testing at Sanofi Pasteur
Thierry Bonnevay, Sanofi

Method Validation Strategy for Endotoxin Testing of Water Samples with Recombinant Factor C
Evelyn Der, Genentech

Results and Benefits of using a Novel Recombinant Factor C Assay for Human Tissue Endotoxin Testing
Victoria Rensink, XTANT Medical

Review of Alternatives to Horseshoe Crab Lysates for Endotoxin Testing
Ned Mozier, Pfizer

Q&A Panel Discussion


10:45 – 12:15 | Plenary 2: Automation/Data Integrity
Moderator: Jessica Hankins, Associate Scientific Director, Microbiology Center of Excellence Analytical Strategy and Operations, Bristol Myers Squibb

Automation technologies for bacterial endotoxin testing can improve efficiency and decrease assay variability. This session will focus on providing end-user perspectives when implementing automation technologies in coordination with bacterial endotoxin testing. Vendor representatives will be present for the Question and Answer session to provide additional insights on the various technologies discussed during the session.

Lessons Learned and Benefits Gained from the Global Implementation of an Automated Endotoxin Testing Solution
Phil Duncanson, PhD, Chief Microbiologist, Global Quality, AstraZeneca

End-User Perspective
Mike Knight, Associate Director, QC Microbiology, Genentech

Holy Crab! A Simple, Automated Sample-to-Answer Recombinant Factor C Assay for Bacterial Endotoxins: A Deeper Dive
Benjamin Claywell, Eli Lilly and Company

Q&A Panel Discussion
  • Josiah Hosie, Lonza
  • Wilhelm Johnsson, Charles River
  • Kevin Miller, Hamilton
  • Kevin Williams, bioMerieux


12:30 – 14:00 | Plenary 3: Current Topics in Endotoxin: The Pyrogenic Dose, Specifications and Co-infusions
Moderator: Jay Bolden, Associate Quality Advisor-Biologist, Global Quality Laboratories, Eli Lilly and Company

This session will link the past to the present, and connect theory to patient safety in a clinical setting. The audience will hear the history and development of the threshold pyrogenic dose as it relates to specification setting, and learn about endotoxins and endotoxemia in the area of global patient safety.

TPD, Rabbits/humans, 2X Safety Factor, Real Endotoxin vs. Purified, Impact of FDA-Requested 2X cut
Karen McCullough, Principal Consultant, MMI Associates, LLC

Clinical Relevance of Specification/Co-infusion Impacts to Patient Safety
Doug Roepke, MD, Medical Fellow, GPS Medical - Product Safety Assessment, Eli Lilly & Company

Q&A Panel Discussion


14:15 – 15:45 | Plenary 4: Regulatory Compendia
Moderator: Ingo Spreitzer, PhD, Deputy Head, Microbiological Safety, Paul-Ehrlich-Institut (PEI)

During the last 20 years new methods in the field of Endotoxin/Pyrogen testing have been developed to marketability. The European Pharmacopeia has incorporated these methods in General Chapters, the pharmaceutical industry is asking for global adjustment (harmonization). Hear perspectives from global pharmacopeias and the FDA on the current position towards rFC (MAT), next steps and harmonization.

EDQM – European Pharmacopoeia Approach to Testing for Pyrogenicity
Emmanuelle Charton, PhD, Head of Division B, European Pharmacopoeia Department EDQM

Japanese Pharmacopoeia on rFC
Yutaka Kikuchi, PhD, Expert Committee, Professor, Department of Nutrition, Faculty of Healthcare Sciences Chiba Prefectural University of Health Sciences, Japanese Pharmacopeia

FDA Vision on rFC and MAT
Reyes Candau-Chacon, PhD, Review Microbiologist, Division of Biotechnology Assessment, CDER, U.S. FDA

Q&A Panel Discussion
Agenda is subject to change.

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