Press release from EDQM regarding Bacterial Endotoxin Test (BET)

Recombinant Endotoxin analysis with the Haemotox® rFC

On December 11, 2019 The European Pharmacopoeia Commission in Strasbourg (EDQM) announced in a Pharmacopoeia (Ph.Eur.) press release that chapter 2.6.32 ("test for bacterial endotoxins using recombinant factor C") shall be included in the 10th edition of the European Pharmacopoeia (Ph.Eur).

The new chapter 2.6.32 shall be published on July 1, 2020 in the Ph.Eur. supplement 10.3 and shall be valid as of January 1, 2021. The planned time schedule may be seen here.

The Haemotox® rFC shall thus be legally equal to the LAL test methods.By the future compendial status of the method it allows the recombinant technology to be implemented without a cross validation. This is a further important step to assure product security without animal related test methods.

The recombinant production of Factor C offers further advantages in comparison to the traditional LAL-testing. False positive results caused by 1,3- beta-D-glucans do not occur. Charge related variations in the sensitivity are unlikely.  

Weblinks:

EDQM Press Release

Ph. eur. 10th edition publication schedule

Literature

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