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Recombinant Reagents: A Regulatory and Technological Journey

Over the past two decades, recombinant reagents have reshaped the landscape of endotoxin testing, offering sustainable, animal-free alternatives to traditional LAL-based methods.

From scientific breakthroughs to regulatory evolutions, endotoxin testing is has undergone major transformations, paving the way for a more efficient and sustainable future.

 

timeline of endotoxin regulatory and technology milestones


 

The future of endotoxin testing is recombinant

The journey from the initial development of recombinant Factor C in 2003 to the comprehensive regulatory frameworks of 2025 highlights the collaborative efforts of scientists, regulatory bodies, and industry stakeholders. This progress not only reflects a commitment to innovation but also a dedication to ethical practices and environmental conservation. 

Implementing and validating a robust method is not a road you have to walk alone! Partnering with bioMérieux for your Quality Control solutions means relying on a trusted and recognized expert to implement recombinant methods into your testing strategies. 

 

 

Endotoxin Testing

Our endotoxin detection solutions are specifically designed to meet the ongoing need for quick, smart, agile laboratory tools while also supporting the initiative to improve the environmental impact of processes and meet  sustainability goals.

References

Ding JL and Ho B (2001) A new era in pyrogen testing. Trends in Biotechnology 19(8): 277–281.
Jeak L. Ding a, Mario A.A. Navas III aBow Ho b Two forms of Factor C from the amoebocytes of Carcinoscorpius rotundicauda: purification and characterization Biochimica et Biophysica Acta (BBA) - Protein Structure and Molecular Enzymology Volume 1202, Issue 1, 3 September 1993, Pages 149-156
Jeak L. Ding Tony Navas Bow Ho Molecular cloning and sequence analysis of Factor C cDNA from the Singapore horseshoe crab, Carcinoscorpius rotundicauda April 1995 Molecular Marine Biology and Biotechnology 4,(1):90-103
A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin
Bruce Loverock, Barry Simon, Allen Burgenson, and Alan Baines, Lonza Walkersville, Inc.Pharmacopeial Forum Vol. 35(6) [Nov.–Dec. 2009]