Monday 16 November 2020

The Development of Recombinant Lysate for Bacterial Endotoxin Testing

The acceptance of recombinant lysate for BET takes a step forwards in 2021 with the coming into effect of a European Pharmacopeia chapter describing a BET that uses a rFC based on the gene sequence of the horseshoe crab for the quantification of endotoxins

In relation to this, Tim Sandle has written a new article. Here is an extract:

The idea for the use of recombinant lysate is to provide a reagent that reacts in the same way as the natural cascade within the four species of horseshoe crab: (Limulus polyphemus, Tachypleus tridentatus, Tachypleus gigas, and Carcinoscorpius rotundicauda). The cloning technology serves an alternative to the fishing and bleeding of horseshoe crabs (where bleeding is performed through a large dorsal blood sinus called the pericardium). In addition, the use of recombinant technology to substitute the specific pathway seeks to address the concern with some lysates that also detect beta glucans through the activation of factor G. A further advantage with recombinant lysates stems from the production of the test reagent through the use of cell culture. This may result in the supply of a more consistent product.

This article attempts to show this through a discussion of the historical perspective, the current situation is a disservice to laboratory users. Much of what has been written on rFC to date has looked at things from a U.S.-centric perspective (rather than U.S. and European) and from a supplier or regulatory perspective; this article embraces the laboratory user perspective.

The reference is:

Sandle, T. (2020) Historical Milestones and Industry Drivers in the Development of Recombinant Lysate for Bacterial Endotoxin Testing, American Pharmaceutical Review, Endotoxin Supplement 2020, pp4-7

For details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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