An in vitro cell-based potency assay for pharmaceutical type A botulinum antitoxins. Issue 52 (19th December 2017)

• Record Type: Journal Article
• Authors: Torgeman, Amram; Diamant, Eran; Levin, Lilach; David, Alon Ben; Epstein, Eyal; Girshengorn, Meni; Mazor, Ohad; Rosenfeld, Ronit; Zichel, Ran
• Is Part Of: Vaccine. Volume 35:Issue 52(2017)
• Page Start: 7213
• Page End: 7216
• Publication Date: 2017-12-19
• Subjects: BoNT botulinum neurotoxin -- SNAREs soluble N-ethylmaleimide-sensitive factor attachment protein receptors -- SNAP-25 25 kDa synaptosomal associated protein -- WHO World Health Organization -- MsLD50 mouse 50% lethal dose -- IIBR Israel Institute for Biological Research -- IU international units -- W/V weight/volume -- BSA bovine serum albumin -- SAT standard antitoxin -- TOX toxin test dose -- HIP hyper-immune plasma -- DS drug substance -- PMNA pharmacopeia mouse neutralization assay; Clostridium botulinum -- Botulinum antitoxin -- Neutralization -- Potency -- In vitro assay; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2017.11.015
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Botulism therapy relies on passive immunization with antitoxin. The mouse neutralization test is the only pharmacopeia assay to measure the potency of antitoxin preparations. Herein, we present an in vitro cell-based assay for the measurement of pharmaceutical type A antitoxin potency. Accuracy, reproducibility and compatibility with the mouse bioassay were demonstrated using different batches of standard antitoxin and toxin preparations. The established assay may substantially reduce the use of laboratory animals in the process of pharmaceutical antitoxin production.