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