Saturday 22 June 2024

Endotoxin testing: the future of recombinant methods (panel)


The most commonly used method for detecting endotoxin in biological drugs for many decades has been Limulus amebocyte Lysate (LAL) based kinetic assays.

The reagent is dependent upon harvesting horseshoe crabs, which places a dependence upon animals and this brings with it ethical, ecological and logistical issues.

New methods are now available which is based on the same reaction principle as LAL but is produced without the need for animal-derived raw material.

These are under the broad terms of ‘recombinant’ endotoxin detection reagents.This was the subject of a recent European Pharmaceutical Review Expert Panel discussion.

Due to advantages of performance and for the other issues it is becoming more important for pharmaceutical companies to evaluate the use of these recombinant technologies.

Peer-reviewed literature was evaluated comparing results obtained with recombinant reagents to those with LAL.

Yet, for laboratory users, there are choices to be made in terms of whether to change, when to change, how to change, and what to change to.

To help to answer these questions, it was my pleasure to chair an expert panel composed of:


  • Ingo Spreitzer, Deputy Head Microbiology Safety Section, Paul-Ehrlich-Institut
  • Radha Tirumalai, Senior Principal Scientist, Merck Research Laboratories
  • Phil Duncanson, an industry expert speaking in a personal capacity
  • Allen Burgenson, SME Testing Services, Lonza


The panel discussed the following questions:


  1. What has been the driver for recombinant lysate?
  2. What is the view of regulators about recombinant lysate?
  3. Where should users begin their journey with recombinant lysate?
  4. How do recombinant reagent test methods differ - recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR)?
  5. How should users approach the selection between these different technologies?
  6. How reliable overall are recombinant lysate solutions?
  7. Are there any products or materials against which recombinant lysate is more challenging?
  8. Do recombinant lysates improve endotoxin test performance?
  9. How should a laboratory approach qualifying a recombinant lysate?
  10. What advice do you have for approaching a regulator for a method change?
  11. What is the likelihood of a unified pharmacopeial approach for recombinant lysate methods?


You can watch the discussion here:


Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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