2021 PDA Endotoxins Workshop
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Individual Registration
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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:- Understand complex interaction of endotoxins with immune system
- Identify the best test method for endotoxin analysis for your company’s purpose
- Select appropriate endotoxin specifications for your company’s products
- Describe best practices for your company’s new or existing laboratories
Contact
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Standard Pricing
Standard Member Price
$1,076GovernmentMember Only
$504
Health AuthorityMember Only
$504
StudentMember Only
$202
AcademicMember Only
$504
Non-Member
$1,328
Day 1
Thursday, 07 October
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08:45 – 10:30 | Plenary 1: Recombinant Reagent 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. |
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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 |
Break
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10:45 – 12:15 | Plenary 2: Automation/Data Integrity 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
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Lunch
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12:30 – 14:00 | Plenary 3: Current Topics in Endotoxin: The Pyrogenic Dose, Specifications and Co-infusions 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. |
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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 |
Break
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14:15 – 15:45 | Plenary 4: Regulatory Compendia 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. |
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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 |
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