Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.
The US Pharmacopeia (USP) published Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents into the United States Pharmacopeia–National Formulary (USP–NF) in November 2024. The chapter permits the use of non-animal-derived reagents for endotoxin testing and is part of USP’s commitment to expanding the use of animal-free methods and materials (1).
Endotoxins, which are present in the environment, can have dangerous effects if they are contained in pharmaceutical products. Gram-negative bacterial endotoxins are difficult to destroy, according to Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories. “When [endotoxins] do end up in a final product, [and] when that [product] is injected or implanted into a patient, it can lead to what we call a pyrogenic response. What that means is the human body is reacting to this contaminant, and it can cause anything from a mild fever all the way through to death. That's the ultimate circumstance of too much endotoxin. So, therefore, most pharmaceutical products that are tested for endotoxin are those that are injectable or implantable and come into contact with the bloodstream, and therefore have to have low levels of endotoxin.”
Watch the latest episode of Ask the Expert in which Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents. https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing
Currently, most manufacturers use the limulus amebocyte lysate (LAL) test to perform endotoxin testing. The LAL test is an animal-derived test, and though the animal itself is not tested upon, there is still concern about the use of animals in testing. Therefore, USP has introduced this new chapter to the USP–NF.
Pharmaceutical Technology® spoke with Reid to get her perspective on endotoxin testing and how the new USP chapter might impact the pharmaceutical industry.
Click on the video above the watch the interview.
1. USP. Expert Committee Approves Endotoxin Testing Using Non-animal Derived Reagents. Press Release. July 26, 2024.
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