论文部分内容阅读
生物制品是具有特定空间结构的生物大分子,其生产工艺要求高,且生产过程极为复杂。生物类似药的生物活性、安全性和有效性与生产工艺密切相关。本文综述了国内外相关法规对生物类似药生产工艺的要求,并以鼠神经生长因子为例介绍生产工艺对其药学特性的影响。在生物类似药的研发和生产中,生产工艺就意味着产品质量。
Biological products are biological macromolecules with specific spatial structure, which require high production process and the production process is extremely complicated. The biological activity, safety and effectiveness of bio-analogs are closely related to the production process. This review summarizes the requirements of the relevant laws and regulations at home and abroad for biologically-based drug production process and gives an example of the effect of production technology on the pharmacological properties of the drug. In the development and production of biological analogs, the production process means product quality.