A recombinant factor C procedure for the detection of gram-negative bacterial endotoxina

Pharmacopeial Forum

Volumn 36, Issue 1, 2010, Pages

  Loverock, Bruce ^a   Simon, Barry ^a   Burgenson, Allen ^a   Baines, Alan ^a   Tirumalai, Radhakrishna ^b  

^a Lonza Walkersville Inc   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ENDOTOXIN; RECOMBINANT FACTOR C PROTEIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG;

CONTROLLED STUDY; ENDOTOXIN DETECTION; GRAM NEGATIVE BACTERIUM; LIMULUS; LIMULUS LYSATE TEST; NONHUMAN; PHOTOMETRY; REVIEW;

EID: 80053168292     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. USP. USP 30-NF 25, Bacterial Endotoxins Test 〈85〉 . Rockville, MD: USP; 2007.
2. USP. USP 30-NF 25, Validation of Compendial Procedures 〈1225〉 . Rockville, MD: USP; 2007.
3. Levin J, Bang FB. Clottable protein in Limulus: its localization and kinetics of its coagulation by endotoxin. Thromb Diath Haemorrh. 1968;19:186-197.
4. Iwanaga S. The Limulus clotting reaction. Curr Opin Immunol. 1993;5:74-82. (Pubitemid 23079451)
5. Nakamura T, Morita T, Iwanaga S. Lipopolysaccharide-sensitive serine-protease zymogen (Factor C) found in Limulus hemocytes. Eur J Biochem. 1986;154:511-521.
6. Muta T, Miyata T, Misumi Y, et al. Limulus Factor C: an endotoxin-sensitive serine protease zymogen with a mosaic structure of complement-like, epidermal growth factor-like, and lectin-like domains. J Biol Chem. 1991;266:6554-6561. (Pubitemid 21906253)
7. Tokunaga F, Nakajima H, Iwanaga S. Further studies on lipopolysaccharide-sensitive serine protease zymogen (Factor C): its isolation from Limulus polyphemus hemocytes and identification as an intracellular zymogen activated by alphachymotrypsin, not by trypsin. J Biochem. 1991;109:150-157.
8. Ding JL, Navas MA, Ho B. Two forms of Factor C for the amebocytes of Carcinoscorpius rotundicauda: purification and characterization. Biochim Biophys Acta. 1993;1202:149-156. (Pubitemid 23269760)
9. Ding J, Navas MA, Ho B. Molecular cloning and sequence analysis of Factor C cDNA from the Singapore horseshoe crab, Carcinoscorpius rotundicauda. Mol Mar Biol Biotechnol. 1995;4:90-103.
10. Ohno N, Emori Y, Yadomae T. Reactivity of Limulus amoebocyte lysate towards (1&ρεγ;3)-β -D-Glucans. Carbohydrate Res. 1990;207:311-318.
11. Pearson F, Bohon J, Lee W, et al. Characterization of Limulus amoebocyte lysate-reactive material from hollow-fiber dialyzers. Appl Environ Microbiol. 1984;48:1189-1196. (Pubitemid 15190692)
12. Chen L. Reckoning recombinant Factor C. Pharm Formulation Quality. 2006;7(December-January):58-60.
13. FDA. Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. Rockville, MD: FDA; 1987.