University of Surrey, Guildford, Surrey, GU2 5XH, UK.
Cytotechnology. 1997 Jan;23(1-3):113-7. doi: 10.1023/A:1007975904301.
The application of quality control and assurance procedures to the components of animal cell cultures has transformed what was an art to a viable industrial technology. This results in the successful large scale operation of such cultures. However it is clear that the cost of obtaining a license to produce materials from animal cells in culture severely impedes the movement of products into the market place. It is therefore necessary to examine in more detail the reasons for the reluctance of the regulatory authorities to issue product licences and in particular to appreciate the way ethical issues influence this process. This paper reviews these issues and indicates a way ahead.
质量控制和保证程序在动物细胞培养物成分中的应用，已经将曾经的一门艺术转化为可行的工业技术。这使得此类培养物的大规模成功运作成为可能。然而，显然从动物细胞培养物中获得生产材料的许可证的成本严重阻碍了产品进入市场。因此，有必要更详细地研究监管机构不愿发放产品许可证的原因，特别是要认识到道德问题如何影响这一过程。本文回顾了这些问题，并指出了前进的方向。
