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An in vitro cell-based potency assay for pharmaceutical type A botulinum antitoxins.
Torgeman, Amram; Diamant, Eran; Levin, Lilach; David, Alon Ben; Epstein, Eyal; Girshengorn, Meni; Mazor, Ohad; Rosenfeld, Ronit; Zichel, Ran.
Affiliation
  • Torgeman A; Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Diamant E; Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Levin L; Cell Culture Research Unit, Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • David AB; Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Epstein E; Cell Culture Research Unit, Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Girshengorn M; Cell Culture Research Unit, Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Mazor O; Antibody Engineering Unit, Department of Biochemistry and Molecular Genetics, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Rosenfeld R; Antibody Engineering Unit, Department of Biochemistry and Molecular Genetics, Israel Institute for Biological Research, Ness Ziona, Israel.
  • Zichel R; Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel. Electronic address: ranz@iibr.gov.il.
Vaccine ; 35(52): 7213-7216, 2017 12 19.
Article in En | MEDLINE | ID: mdl-29174678
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Assay / In Vitro Techniques / Botulinum Antitoxin Limits: Animals Language: En Journal: Vaccine Year: 2017 Document type: Article Affiliation country: Israel
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Assay / In Vitro Techniques / Botulinum Antitoxin Limits: Animals Language: En Journal: Vaccine Year: 2017 Document type: Article Affiliation country: Israel