Vaccine manufacturing and technology: from biotechnological platforms to syntethic epitopes, current viepoint.

G A Ignateva
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Abstract

The purposes: The Purposes: the review take into account short history of vaccination practice and development of vaccine technology.

Methods: In the review we include data from several monographs about manufacturing of vaccines published by authors from such companies as Merck & Co; Sanofi Pasteur; Dynavax Europe/Rhein Biotech GmbH; Latham Biopharm Group; Aridis Pharmaceuticals LLC; Genentech; Amgen; Shamir Biologics LLC; Biopharm Services US; Novartis Pharma AG, аnd several research centers: Laboratory of Bacterial Polysaccharides, Center for Biologics Evaluation and Research; Purdue University, West Lafayette, IN, US; Department of Pharmaceutical Chemistry, Univ. Of Kansas; Max Planck Institute for dynamics of Complex Technical Systems; Fraunhofer USA Center for Molecular Biotechnology; US Dep. of Agriculture Animal and Plant Health Inspection Service, etc.

Results: In historic literature there are data about inoculation practices in antique China, Persia, India, Byzantium, native Americans, some African population. In modern immunology since the end of XIX century the vaccines were produced at the in vivo platforms - in animals (rabbits, mice, cows). Since 1931 due to E. Goodpasture' elaboration most virus vaccines were and are produced at the in ovo platform. In 1949 J.F. Enders elaborated large-scale polio virus production in the primary culture of monkey kidney cells in vitro. Up to day primary culture of chiken embrio fibroblasts are used to large-scale production of vaccine viruses of measles, mumps, rabies. Since 2000-th in Western countries most part of virus vaccines were began to produced via a cultivation in continuous tumor cell lines. The last technology is the most low cost for large-scale production of vaccines. We review several new biotechnological platforms for the production of the recombinant protein or virus-like particles as subunit vaccines: plant system, algae, mushrooms, insect cells, etc.

Conclusion: Beside of good purpose of vaccination - prophylactic of several infectious deseases, doctors must take into account possibility of inter-species transmission of unknown pathogens (retroviruses, prions, etc) from biotechnological platforms - animals, cell cultures - into human population, and don't ignore L.A. Zilber' theory of virus' etiology of cancer diseases.

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疫苗制造和技术:从生物技术平台到合成表位,当前观点。
目的:目的:本综述考虑了疫苗接种实践的短历史和疫苗技术的发展。方法:在这篇综述中,我们纳入了几本关于疫苗生产的专著的数据,这些专著的作者来自Merck & Co;赛诺菲巴斯德;Dynavax Europe/Rhein Biotech GmbH;Latham Biopharm Group;Aridis Pharmaceuticals LLC;基因泰克公司;安进公司;Shamir Biologics LLC;美国生物制药服务公司;诺华制药有限公司和几个研究中心:细菌多糖实验室,生物制品评价与研究中心;普渡大学,西拉斐特,美国;美国堪萨斯大学药物化学系;马克斯·普朗克复杂技术系统动力学研究所;美国弗劳恩霍夫分子生物技术中心;结果:在历史文献中有关于古代中国、波斯、印度、拜占庭、美洲原住民和一些非洲人口接种的资料。自19世纪末以来,在现代免疫学中,疫苗是在体内平台上生产的-在动物(兔子,老鼠,奶牛)中生产的。自1931年以来,由于E. Goodpasture的精心设计,大多数病毒疫苗过去和现在都是在蛋内平台生产的。1949年,J.F.恩德斯详细阐述了在体外原代培养猴肾细胞中大规模生产脊髓灰质炎病毒。目前,鸡胚成纤维细胞的原代培养已被用于大规模生产麻疹、腮腺炎、狂犬病疫苗病毒。自2000年以来,在西方国家,大部分病毒疫苗开始通过在连续肿瘤细胞系中培养来生产。最后一项技术是大规模生产疫苗成本最低的技术。本文综述了几种新的生产重组蛋白或病毒样颗粒作为亚单位疫苗的生物技术平台:植物系统、藻类、蘑菇、昆虫细胞等。除了疫苗接种的良好目的——预防几种传染病之外,医生必须考虑未知病原体(逆转录病毒、朊病毒等)从生物技术平台——动物、细胞培养物——向人类传播的可能性,不要忽视L.A. Zilber癌症疾病的“病毒”病因学理论。
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