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Sorting out of Interference in Detection of Endotoxins in Biotherapeutic Drugs
The effect of varying interference factors responsible for false positive results was investigated. The interfering factors inhibiting the endotoxins in activated lymphocytes sample was sorted by heat denaturation. These activated lymphocytes are biotherapeutic drugs which are used for autologous immune enhancement therapy. The technique used for denaturation can be applied to protein samples as well, to get rid of inhibition while quantifying endotoxins.
Keywords
LAL, CSE, Bacterial Endotoxin, Endotoxin Limit and Interference
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- Bang FB (1956) A bacterial disease of Limulus polyphemus. Bull. Johns Hopkins Hosp. 58, 325-351.
- Cooper JF (1990) Resolving LAL test interferences. J. Parenteral Sci.Tech. 44, 13-15.
- FDA LAL Test Guideline (2009) Bacterial endotoxin test. USP 32 (85).
- Mc Closky WT, Prince CW, Van Winkle WJ, Welch H and Calvery HO (1943) Results of first USP collaborative study of pyrogens. J. Am. Pharm. Assoc. 32, 69-73.
- Good CM and Lane Jr. HE (1977) The biochemistry of pyrogens. Bull. Parenter. Drug Assoc. 31, 116-120.
- Pearson FC (1991) Limulus amebocyte lysate testing: comparative methods and reagents. In: Sterile Pharmaceutical Manufacturing: Applications for the1990s. Eds. Groves MJ, Olson WP & Anisfe1d MH, Vo1.2. Interpharm Press. pp: 185-197.
- Sullivan JD and Watson SW (1975) Purification and properties of the clotting enzyme from Limulus lysate. Biochem. Biophys. Res. Commun. 66, 848-855.
- USP 24-NF (1999) Bacterial Endotoxins Test. 2nd Supplement, 85. The USP Convention, Rockville, MD. pp: 2875-2879.
- van Noordwijk J and DeJong Y (1977) Comparison of the LAL test with the rabbit test: false positives and false negatives. Dev. Boil. Stand. 34, 39-43.
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