An in vitro cell-based potency assay for pharmaceutical type A botulinum antitoxins.
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.
Key words
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