Evens R P, Witcher M
Manufacturing Department, Amgen Inc., Thousand Oaks, California 91320.
Ther Drug Monit. 1993 Dec;15(6):514-20.
Exciting advances in biotechnology have led to the development of innovative biological products to improve health care. In this review article, the major techniques of product development and manufacturing in biotechnology are discussed, with a focus on recombinant DNA technology. In addition, monoclonal antibody, nucleotide blockade, polymerase chain reaction, antisense, and gene therapy technologies will be defined briefly. For recombinant-DNA technology, the issues of gene isolation, gene cloning, protein expression, scale-up (manufacturing), and quality assurance are addressed. The 16 approved products and the research pipeline are characterized. In addition, major usage issues for biological products are noted. This review serves as an introduction to the science and applications of biotechnology present and future.
生物技术领域令人振奋的进展推动了创新生物产品的开发，以改善医疗保健。在这篇综述文章中，讨论了生物技术产品开发和制造的主要技术，重点是重组DNA技术。此外，还将简要介绍单克隆抗体、核苷酸阻断、聚合酶链反应、反义技术和基因治疗技术。对于重组DNA技术，还探讨了基因分离、基因克隆、蛋白质表达、放大生产（制造）和质量保证等问题。对16种已获批产品和研究进展进行了描述。此外，还指出了生物产品的主要使用问题。这篇综述是对当前和未来生物技术科学与应用的介绍。
