Recommended

New webinar with Fujifilm: Monocyte activation test (MAT): Insight into examining regulations and markets prospects
New webinar: The path to optimisation in pharmaceutical microbiology
Join our webinar: An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
Discover more in our new application note: validating recombinant cascade reagents in 3 simple steps
Advertorial

Article: Survey of the status of rFC and LAL equivalence determination

Posted: 29 June 2021 | | No comments yet

While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.

Peer-reviewed studies testing a range of products (buffers, purified water, biologics and vaccines) show equivalent reactivity. A singular test showing non-equivalence used uncharacterised water and should be viewed in light of well documented caveats.

Comparison studies are a validation test as per USP <1225> and require the use of characterised materials to support specificity and reproducibility determination. Uncharacterised substances, including pre-filtration water, are not products, are not validated and are not routinely tested in pharmaceutical manufacturing. The US Food and Drug Administration (FDA) comments on USP <1085.1> draft chapter have said that such waters should not be used for such purposes. For these reasons, the study included here by a Limulus amebocyte lysate (LAL) manufacturer was issued an “Expression of Concern” addendum by its publisher.1

    To read this article in full, please complete the form below:

     









    This specialist content is provided to you free-of-charge thanks to the kind support of bioMérieux

    By clicking submit you confirm that you accept our terms and conditions and privacy policy.