Hayakawa T
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1999(117):1-38.
Recent progress in biotechnology, including recombinant DNA (rDNA) technology and cell culture technology, has enabled us to produce new medically useful agents intended for human use. These agents include therapeutic peptides and proteins derived from rDNA-modified cell substrates, continuous cell lines, diploid cell lines, and hybridoma cell lines, gene therapy products, cellular therapy products, and therapeutic protein products and cellular products derived from transgenic animals. To enable these products to be of use in human therapy, it is essential that suitable measures be taken by manufacturers and regulatory authorities to assure their quality, efficacy, and safety. This article describes points based on the latest sound scientific principles to be considered when producing, testing, evaluating and controlling biotechnology products for human therapy, especially with respect to their characteristics, quality, and safety.
生物技术的最新进展，包括重组DNA（rDNA）技术和细胞培养技术，使我们能够生产用于人类的新型医学有用制剂。这些制剂包括源自rDNA修饰细胞底物、连续细胞系、二倍体细胞系和杂交瘤细胞系的治疗性肽和蛋白质、基因治疗产品、细胞治疗产品以及源自转基因动物的治疗性蛋白质产品和细胞产品。为使这些产品能够用于人类治疗，制造商和监管当局必须采取适当措施，以确保其质量、疗效和安全性。本文介绍了在生产、测试、评估和控制用于人类治疗的生物技术产品时，特别是考虑到其特性、质量和安全性，应依据最新可靠科学原则考虑的要点。
