第五章。肽制造方法和挑战

S. Kota
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引用次数: 1

摘要

多肽通过液相或固相多肽合成、固相和固相混合合成或重组DNA技术进行商业化生产。应用于商业生产的技术是由肽的大小和性质决定的。由于多肽中的杂质通常与目标产品中的杂质相似,因此纯化和分离等下游处理步骤对于生产高度纯化的活性多肽药物成分具有重要意义,这些活性多肽药物成分符合严格的监管要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Chapter 5. Peptide Manufacturing Methods and Challenges
Peptides are manufactured commercially by liquid- or solid-phase peptide synthesis, by hybrid synthesis using both solid- and solution-phase synthesis or by using recombinant DNA technologies. The technology applied to commercial manufacturing is determined by the size and nature of the peptide. Since the impurities in peptides tend to be generally similar to those in the product of interest, downstream processing steps such as purification and isolation are significant for producing highly purified active peptide pharmaceutical ingredients that meet the stringent regulatory requirements.
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