Recombinant Factor C (rFC) Endotoxin Detection Kit

Overview

Overview

Every LNP formulation destined for injection must clear endotoxin testing before release. This kit does it without horseshoe crab blood: recombinant Factor C (rFC) recognises bacterial endotoxin and cleaves a fluorogenic substrate — the stronger the signal, the higher the endotoxin load. Unlike traditional LAL assays, rFC contains no Factor G and is not fooled by β-glucans, so false positives are rare and batch-to-batch consistency is high. It is the direction global regulators and the industry are moving in.

Key specifications

Method validation

Specificity, sensitivity, precision, accuracy and suitability validated following European Pharmacopoeia EP 11.0 and USP <1225> / <86>. The endotoxin standard is traceable to USP reference standard.

Pack sizes

Kit contents (96 tests)

Samples and applications

Injectables, biologics, infusion cells, medical devices and cell culture media — plus in-process control of raw water, intermediates and finished product. Especially suited to samples containing β-glucans that trigger false positives in traditional LAL assays, and to LNP / mRNA release testing prior to animal administration.

Key features

• No β-glucan interference — no Factor G in the kit, unlike LAL reagents
• Sensitive and wide-ranging — quantification down to 0.005 EU/mL
• Fast — results in about 1 hour, handling comparable to chromogenic LAL
• Traceable — endotoxin standard traceable to USP reference material
• Animal-free and supply-stable — recombinant production, consistent between batches, aligned with global regulatory direction away from animal-derived reagents

Notes

• Requires a fluorescence microplate reader capable of 380 / 440 nm, plus endotoxin-free tips and glassware (the kit includes one endotoxin-free black plate). This is an instrumental readout assay, not visual judgement.
• Catalogue numbers, COA and the full validation report are confirmed at enquiry.
• For Research Use Only. Not a drug and not a diagnostic reagent; supplied exclusively for research applications.
• Certification documents available on request and verifiable by certificate number. FOB pricing, MOQ and lead time quoted at enquiry.