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Journal of Clinical Microbiology, August 2003, p. 3687-3689, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3687-3689.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

New Generation of Cell Culture Assay for Smallpox Vaccine Potency

Isabelle Leparc-Goffart,1* Bertrand Poirier,1 Annie El Zaouk,2 Marie-Hélène Tissier,3 and Florence Fuchs1

Agence Française de Sécurité Sanitaire des Produits de Santé, 69007 Lyon,1 Agence Française de Sécurité Sanitaire des Produits de Santé, 34740 Vendargues,2 Agence Française de Sécurité Sanitaire des Produits de Santé, 93285 Saint-Denis, France3

Received 25 February 2003/ Returned for modification 14 April 2003/ Accepted 16 May 2003

The potency of smallpox vaccines produced in the 1970s was tested by titration onto chorioallantoic membranes of fertilized hen eggs (CAM assay). The potency specification commonly approved for these vaccines was a titer above 108 pock-forming units per milliliter. We developed and validated a cell culture titration assay to have a more reliable potency test. The cell titration assay and the CAM assay were tested in parallel on 34 first-generation smallpox vaccine lots. These allowed us to demonstrate that a correlation does exist between the two titration techniques and to determine a new in-house specification for the cell titration method. This in vitro potency assay will allow us to test first-generation smallpox vaccines produced on the skin of living animals but will also give a hint of the potency specification that should be assigned for new generations of cell-derived smallpox vaccines.

* Corresponding author. Mailing address: Agence Française de Sécurité Sanitaire des Produits de Santé, 321 avenue Jean Jaurès, 69007 Lyon, France. Phone: (33) 4 72 76 06 10. Fax: (33) 4 72 76 06 15. E-mail: Isabelle.Leparc-Goffart{at}afssaps.sante.fr.

Journal of Clinical Microbiology, August 2003, p. 3687-3689, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3687-3689.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.





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