TABLE I

Recent Peer-Reviewed Articles on the Use of Recombinant Reagents for Endotoxin Testing

  1. Comparison of Limulus amebocyte lysate test methods for endotoxin measurement in protein solutions, J. Pharm. Biomed. Analysis–Chen, L. and Mozier, N. (2013)

  2. Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-based Procedure for Detection of Lipopolysaccharides, PMDA– Kikuchi, Y., et al., (Part 1) (2017)

  3. Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-based Procedure for Detection of Lipopolysaccharides, PMDA–Kikuchi, Y., et al., (Part 2) (2017)

  4. Results of a harmonized endotoxin recovery study protocol evaluation by 14 BioPhorumOperations Group (BPOG) member companies, Biologicals–Bolden J., et al. (2017)

  5. Application of recombinant Factor C reagent for the detection of bacterial endotoxins in pharmaceutical products, PDA-JPST–Bolden, J. and Smith, K. (2017)

  6. Study on the Applicability of Recombinant Factor C Method for Detection of Bacterial Endotoxin, China Pharmaceuticals–Pei, Y., et al. (2019)

  7. Application of a Recombinant Three-Factor Chromogenic Reagent, PyroSmart, for Bacterial Endotoxins Test Filed in the Pharmacopeias, Biol. Pharm. Bull–Muroi, M., et al. (2019)

  8. Comparison of LAL and rFC Assays-Participation in a Proficiency Test Program between 2014 and 2019, Microorganisms–Piehler, M., et al. (2020)

  9. Comparison of LAL and recombinant Factor C endotoxin testing assays in human vaccines with complex matrices, PDA-JPST– Marius, M., et al. (2020)

  10. Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices, Biologicals–Marius, M., et al. (2020)

  11. Evaluation of recombinant factor C assay for the detection of divergent lipopolysaccharide structural species and comparison with Limulus amebocyte lysate-based assays and a human monocyte activity assay, J. Med. Microbiol.–Abate, W., et al. (2017)