Process for the large-scale production of a vaccine against

Abstract

A process for large-scale production of poliomyelitis vaccine separately entails, for each type of poliomyelitis virus used, the following steps. A cell strain, using a cell stock, is multiplied by culturing the same in a liquid nutritive medium on microcarriers in suspension and by successive passages into biogenerator of increasing volumes. The last biogenerator is one having a capacity of at least 150 liters and the nutritive medium contains serum. This operation is carried out with stirring at a rate not greater than 40 rpm. At the end of the final passage the liquid nutritive medium is withdrawn and replaced by one that is serum-free. The biogenerator used for the last passage is then inoculated with virus which is permitted to develop, again with stirring at a rate not greater than 40 rpm. After virus culture, the liquid suspension is withdrawn, filtered, concentrated at least 150 times by ultrafiltration, subjected first to gel filtration and then to ion exchange chromatography. The resulting concentrated suspension is diluted with a serum-free medium and then inactivated. The suspensions of the respective types used are mixed from which individual dosages are prepared.