Recombinant Factor C Characterization Studies Confirm the Published Structure and Function of Manufactured rFC

Introduction

With the advent of first the EU Pharmacopeial Chapter 2.6.32 (2020) and now the publication of USP Chapter <86> (2024) on the use of recombinant Factor C assays, the manufactured products supplied must meet customer confidence expectations in terms of r-Protein characterization. Both current and historical QC characterization tests are described here for ENDOZYME II. The known and therefore expected structure of the complex molecule is shown below from: Shibata et al. 2018 “Intermolecular autocatalytic activation of serine protease zymogen factor C through an active transition state responding to lipopolysaccharide” (1).

Complete the form below to access the poster, which will be sent directly to your email after submission. By providing your information, you agree to receive additional emails from bioMérieux about endotoxin testing.