Frommer W, Archer L, Boon B, Brunius G, Collins C H, Crooy P, Doblhoff-Dier O, Donikian R, Economidis J, Frontali C
DECHEMA, Frankfurt/Main.
Appl Microbiol Biotechnol. 1993 May;39(2):141-7. doi: 10.1007/BF00228597.
The benefits of using animal or human cell cultures have been clearly demonstrated in diagnostic and therapeutic research and in their application for manufacturing. Cell cultures serve as a tools for the production of vaccines, receptors, enzymes, monoclonal antibodies and recombinant DNA-derived proteins. They represent an integral part of drug development for which corresponding facilities, equipment and manufacturing processes are required. Although the cells themselves offer no particular risk to workers in laboratories and production areas or to the environment, the cell cultures may be contaminated with viruses, mycoplasma, bacteria, yeast and fungi or might contain endogenous viruses. The containment level for animal and human cells is therefore determined by the risk class of these agents. The history of animal and human cell cultures has proved that they can be handled safely. The recommendations in this publication concern the safe handling of cell cultures (tissue explants, primary cell cultures) and permanent cell lines of animal and human origin. A classification system of safety precautions has been elaborated according to the potential for contamination with the pathogenic agents involved.
使用动物或人类细胞培养物的益处已在诊断和治疗研究及其制造应用中得到明确证明。细胞培养物可作为生产疫苗、受体、酶、单克隆抗体和重组DNA衍生蛋白的工具。它们是药物开发不可或缺的一部分,为此需要相应的设施、设备和制造工艺。尽管细胞本身不会对实验室和生产区域的工作人员或环境构成特殊风险,但细胞培养物可能会被病毒、支原体、细菌、酵母和真菌污染,或者可能含有内源性病毒。因此,动物和人类细胞的防护水平取决于这些病原体的风险等级。动物和人类细胞培养物的历史证明,它们可以安全处理。本出版物中的建议涉及动物和人类来源的细胞培养物(组织外植体、原代细胞培养物)和永久细胞系的安全处理。已根据所涉及病原体的污染可能性制定了安全预防措施分类系统。