Montagnon B J, Fanget B, Vincent-Falquet J C
Rev Infect Dis. 1984 May-Jun;6 Suppl 2:S341-4. doi: 10.1093/clinids/6.supplement_2.s341.
In 1980, the authors reported preliminary results of large-scale production of inactivated poliovirus vaccine in which virus was produced in Vero cell culture on a microcarrier. For this first stage of development, 150-liter tanks were used. The virus is now produced in 1,000-liter tanks. The main point concerning the quality of Vero cells, namely the absence of tumorigenicity, has been demonstrated, qualifying them for use in the Institut M erieux cell bank. The purity of the cell line has also been determined by checking for the absence of bacteria, fungi, mycoplasmas, and viruses. The search for oncornavirus and for reverse transcriptase activity was carried out, and the results were negative but are not described in this paper. The quality of the purification process was checked by a search for residual cellular DNA in concentrated, purified, and inactivated vaccine. With use of a molecular hybridization procedure, a specific probe was prepared to detect approximately 50 pg of DNA per filter. The preliminary results show that the purification procedure fulfills the World Health Organization's requirements. T1 oligonucleotide mapping has also shown the identity of poliovirus RNA extracted from virus grown on Vero cells and that from primary monkey kidney cells. These data have led to the awarding of a license by the French government to the Institut M erieux for production of this new, reassessed, inactivated poliovirus vaccine.
1980年,作者报告了在微载体上的非洲绿猴肾细胞培养物中大规模生产灭活脊髓灰质炎病毒疫苗的初步结果。在开发的第一阶段,使用了150升的罐体。现在病毒在1000升的罐体中生产。关于非洲绿猴肾细胞质量的要点,即无致瘤性,已经得到证实,使其有资格用于梅里埃研究所的细胞库。细胞系的纯度也通过检查是否存在细菌、真菌、支原体和病毒来确定。进行了对肿瘤病毒和逆转录酶活性的检测,结果为阴性,但本文未作描述。通过在浓缩、纯化和灭活疫苗中寻找残留细胞DNA来检查纯化过程的质量。使用分子杂交程序,制备了一种特异性探针,以检测每个滤膜上约50皮克的DNA。初步结果表明,纯化程序符合世界卫生组织的要求。T1寡核苷酸图谱也显示了从在非洲绿猴肾细胞上生长的病毒中提取的脊髓灰质炎病毒RNA与从原代猴肾细胞中提取的脊髓灰质炎病毒RNA的一致性。这些数据使得法国政府授予梅里埃研究所生产这种重新评估的新型灭活脊髓灰质炎病毒疫苗的许可。