Roulet C, Favre H, Mougeot H, Brun A, Fargeaud D, Dubouclard C
Dev Biol Stand. 1976;35:79-90.
The characteristics of the viruses produced from cell lines developed in suspension and the vaccines for which they are used should be judged by methods which allow to ensure in all cases their innocuity and efficacity. Innocuity is essentially dependent upon the purity of the viral preparation which should contain a minimum of foreign proteins (due either to the cell or the culture medium) and certain antibiotics. Furthermore, the absence of oncogenic properties of the inactivated viral suspensions should be shown, in addition to their specific innocuity. Efficacity is linked with the concentration of viral particles and with their immunogenic properties after inactivation and incorporation of adjuvants of immunity. Methods of appreciation of the different parameters are proposed.
对悬浮培养的细胞系所产生的病毒及其所制成疫苗的特性,应通过能确保在所有情况下其安全性和有效性的方法来评判。安全性主要取决于病毒制剂的纯度,该制剂应含有最少的外源蛋白(源于细胞或培养基)以及某些抗生素。此外,除了其特定的安全性外,还应证明灭活病毒悬液无致癌特性。有效性与病毒颗粒的浓度及其在灭活和加入免疫佐剂后的免疫原性相关。文中提出了评估不同参数的方法。