Kuhlmann Ingrid, Kurth Waltraud, Ruhdel Irmela
Tierforschungsanlage, Universität D-Konstanz.
ALTEX. 1989;6(2):12-26.
Monoclonal antibodies are valuable tools in medical and biological research which can be used for identifying, characterizing and purifying medically and biologically important substances. Due to their high specificity monoclonal antibodies are more and more used in the diagnosis and therapy of infectious diseases and tumor illnesses. Large amounts of antibodies are needed for use in these areas and this necessitates mass production (g - kg range). Many production systems and possibilities for optimizing mass production have been described. In contrast, at universities and other research institutions the production of monoclonal antibodies in laboratory scale (mg range) is still carried out mostly in the ascites mouse. This article described our own experiences and results with the in vitro production in mg range. Using the German animal protection law (22.8.1986) as an example the legal aspects of animal protection in the production of monoclonal antibodies are discussed. In addition the legal regulations in Switzerland and the Netherlands are presented.
单克隆抗体是医学和生物学研究中的宝贵工具，可用于鉴定、表征和纯化医学和生物学上重要的物质。由于其高度特异性，单克隆抗体越来越多地用于传染病和肿瘤疾病的诊断和治疗。这些领域需要大量抗体，这就需要大规模生产（克至千克范围）。已经描述了许多生产系统以及优化大规模生产的可能性。相比之下，在大学和其他研究机构，实验室规模（毫克范围）的单克隆抗体制备大多仍在小鼠腹水中进行。本文介绍了我们自己在毫克范围内体外制备的经验和结果。以德国动物保护法（1986年8月22日）为例，讨论了单克隆抗体制备中动物保护的法律问题。此外，还介绍了瑞士和荷兰的法律法规。
