Recombinant Factor C Adopted into Ph. Eur.

The European Pharmacopoeia (Ph. Eur.) Commission has officially adopted general chapter 2.6.32 Test for Bacterial Endotoxins using Recombinant Factor C!

The EDQM (European Directorate for the Quality of Medicines) announced this in a press release on 11 December 2019. After releasing a draft text for comment in November 2018, the European Pharamacopoeia is now taking the next step to make endotoxin testing with recombinant Factor C (rFC) a compendial method in Europe. This is exciting news for users of Lonza’s PyroGene^® recombinant Factor C assay, as it will allow customers to use rFC without the necessity for an alternative method validation. The new chapter 2.6.32 is announced to be published on 01 July 2020 in Ph.Eur. supplement 10.3 and will be effective as of 01 January 2021. As per EDQM’s FAQ, authorities usually accept practical application of a text after the publication date, prior to the implementation date.

We’ll keep you updated with more information as it becomes available!

Written by Saskia

Scientific Support Specialist

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Article overview

Comparing endotoxin testing results of modern recombinant to traditional LAL methods

Learn about Jay Bolden and co-workers extensive study of peer-reviewed literature to find publications where naturally contaminated samples were tested side by side (same samples, only difference being the test method, i.e. rFC vs LAL/TAL).

From LAL to rFC assay

Explore the history of LAL endotoxin testing towards the development of the recombinant Factor C assay. The American horseshoe crab population is now a vulnerable species, just one step from being endangered. The rFC assay has gone a long way to be accepted but as there is a growing recognition of its importance by various Pharmacopeia, a widespread adoption of the rFC method could be on the horizon.

Confidence for adopting the rFC method in your lab

Different aspects of the endotoxin testing are considered to shed some light on articles that question the use of rFC for release testing.

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