Ogez J R, Hodgdon J C, Beal M P, Builder S E
Genentech, Inc., South San Francisco, CA 94080, USA.
Biotechnol Adv. 1989;7(4):467-88. doi: 10.1016/0734-9750(89)90719-2.
This review on the downstream processing of proteins describes innovations that have occurred in the field since 1983. Several areas have seen particularly high levels of achievement, and are accorded expanded coverage relative to our previous review [1]. As an example, the increasing integration of downstream operations with upstream technologies, such as molecular biology and fermentation, has led to the development of some very powerful processes. The degree to which organizations understand that there needs to be one unified process, rather than the independent steps of cloning, fermentation and recovery, seems directly related to the ultimate speed and success of the development effort. In 1983 one of the most active development areas was chromatography, especially affinity chromatography. This is still true today, and this topic has been expanded to include biospecific adsorptions that would not traditionally be classified as chromatography. With more proteins being developed for human administration, there has been an increased emphasis on all aspects of process hygiene. In addition, there has been much discussion about the impact of regulatory demands on the design and development of the manufacturing processes. Therefore, a section has been added which covers several of the regulatory issues that have been raised for products of the new biotechnology. Finally, as some of the early process development achievements are now beginning to bear fruit in the form of patents, we have increased our citation of this area of the literature.
这篇关于蛋白质下游加工的综述描述了自1983年以来该领域所发生的创新。有几个领域取得了特别高的成就，相对于我们之前的综述[1]，对这些领域的覆盖范围有所扩大。例如，下游操作与上游技术（如分子生物学和发酵）的日益整合，催生了一些非常强大的工艺。各机构对需要一个统一的工艺，而非克隆、发酵和回收等独立步骤的理解程度，似乎直接关系到开发工作最终的速度和成功与否。1983年，最活跃的开发领域之一是色谱法，尤其是亲和色谱法。如今仍是如此，并且这个主题已扩展到包括传统上不归类为色谱法的生物特异性吸附。随着越来越多的蛋白质被开发用于人体给药，人们对工艺卫生的各个方面都更加重视。此外，关于监管要求对制造工艺设计和开发的影响也有很多讨论。因此，增加了一个章节，涵盖了针对新生物技术产品提出的若干监管问题。最后，由于一些早期工艺开发成果现在开始以专利的形式取得成果，我们增加了对该文献领域的引用。
