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Bacterial Endotoxin Test and Wako

We contributed to the establishment of the bacterial endotoxin test method etc. from the dawn of the test and have supported the development and dissemination of bacterial endotoxin test as well as the development of measurement system etc. meeting the needs of present age.

Bacterial Endotoxin test Our LAL business
1950-1956 Bang conducted the blood clotting study of horseshoe crabs.
1964 Levin & Bang discovered the endotoxin to clot the blood corpuscles of horseshoe crabs. * 1
1970 Cooper, Levin, Wagner and others announced the possibility that LAL could be an alternative method to the rabbit pyrogen test (pyrogen test using rabbits). * 2
1979 Release of gel-clot technique reagents in Japan.
1980 Gel-clot technique were listed in the USP (US Pharmacopoeia) as Bacterial Endotoxins Test (BET).
1985 Release of Toxinometer
1987 FDA issued Validation Guidelines for Limulus Test.
1988 Bacterial endotoxin test method (gel-clot technique) was listed in the Japanese Pharmacopoeia.
(supplement 1 of the 11th edition)
 
1993 The international harmonization work on bacterial endotoxin test method was started.
1994 Release of Limulus ES-II
1996 In addition to the gel-clot technique, the turbidimetric technique and the chromogenic technique were listed in the Japanese Pharmacopoeia (the 13th edition). The first Bacterial Endotoxin Test Method Seminar was held.
Release of Limulus Color KY.
1999 Each country's pharmacopoeia signed the harmonization agreement in BET international harmonization plan.  
2000 LAL business was started at Wako Chemicals USA Inc.
2010 Abolition of FDA Guideline for Limulus test.
(Unified to USP BET)
Release of Toxinometer ET-6000
2011 FDA Guidance "Pyrogen and Endotoxins Testing: Q & A" was issued. Wako Chemicals USA Inc.,:
Richmond plant acquired FDA approval.
2012 International harmonization agreement of bacterial endotoxin test method. Release of PYROSTAR ES-F
2013 BET International harmonization agreement
Japan: March 21, 2013, Europe: May 2013,
The United States: enforced on October 15, 2013.
2015   Release of Limulus ES-Ⅱplus CS

【References】
*1:Levin,J. and Bang,F.B. Bull. Johns Hopkins Hosp.,115,265 (1964)
*2:Cooper JF, Levin J, Wagner HN. J Nucl Med 11,310 (1970)

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  • LAL Basic Knowledge
  • Lysate reagent selection flowchart

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