Kistner O, Barrett N, Mundt W, Reiter M, Schober-Bendixen S, Eder G, Dorner F
Biomedical Research Center, Baxter Vaccine AG, A-Orth/Donau.
ALTEX. 2001;18(1):50-4.
Influenza viruses for production are presently produced in embryonated hen"s eggs. This conventional standard methodology is extremely cumbersome; it requires millions of eggs and an extensive purification to reduce the amount of contaminating egg proteins and to minimise the risk of allergies against egg albumin. The shortage of eggs in a pandemic situation, the selection of egg-adapted variants and the presence of adventitious viruses has emphasised the necessity for production of Influenza vaccines on a well characterised stable cell line. Our established serum and protein free Vero cell technology has been successfully adapted to large scale production of a huge variety of Influenza virus strains. The production in 1200 liter fermenter cultures under serum free conditions gave antigen yields comparable to the conventional embryonated egg technology. The development of a rapid and efficient purification scheme resulted in a safe high purity vaccine which was at least as immunogenic as conventional egg-derived vaccines in a mouse model. Clinical trials in the UK, Poland and Austria demonstrated that the Vero cell derived influenza vaccine is well tolerated, safe and highly immunogenic in humans.
目前用于生产的流感病毒是在鸡胚中培养的。这种传统的标准方法极其繁琐；它需要数百万枚鸡蛋，并进行广泛的纯化以减少污染的鸡蛋蛋白量，并将对卵清蛋白过敏的风险降至最低。大流行情况下鸡蛋的短缺、适应鸡蛋的变异株的选择以及偶然病毒的存在，凸显了在特征明确的稳定细胞系上生产流感疫苗的必要性。我们成熟的无血清和无蛋白Vero细胞技术已成功应用于多种流感病毒株的大规模生产。在无血清条件下于1200升发酵罐培养物中生产的抗原产量与传统的鸡胚技术相当。快速高效的纯化方案的开发产生了一种安全的高纯度疫苗，在小鼠模型中其免疫原性至少与传统的鸡蛋衍生疫苗相同。在英国、波兰和奥地利进行的临床试验表明，Vero细胞衍生的流感疫苗在人体中耐受性良好、安全且具有高度免疫原性。
