大规模培养动物细胞生产药物

Large Scale Animal Cell Cultures for the Production of Therapeutic Biologicals

细胞融合与重组DNA技术取得的巨大成功为动物细胞培养技术开辟了许多新的领域。目前各类具有明确疗效的生物制品(如病毒疫苗、基因工程蛋白质和单克隆抗体等)的工业化生产已成为动物细胞培养技术发展的主要动力。动物细胞大规模培养技术的研究开发,除了要解决如何高效地大量生产这些药物之外,其生产过程必须确保产品质量能适合人体治疗,且不含有害物质,尤其是病毒和DNA。经过十几年的努力,符合上述要求的生产方法已初步建立,本文拟就此作一简要综述。

The advent of cell fusion and recombinant DNA technlolgies has resulted in a burgeoning number of applications for animal cell culture technology. At present the industrial productions of the therapeutic biologicals(such as viral vaccines,recombinant proteins,and monoclonal antibodies)become the main driving force for the development of large-scale bioprocesses using animal cells. In addition to providing the way how to produce the required quantities of these biologicals effectively,the large scale animal cell culture technology and the manufacturing processes must also be designed to ensure that the products have appropriate quality for human therapeutic use and are free of potentially harmful contaminants,especially viruses and DNA. Through the considerable effort having been paid during the past decade, the manufacturing methods are now available to meet the above requirements.