重组蛋白药物的生产技术进展

Progress on the Production Technology of Recombinant Therapeutic Proteins

重组蛋白药物是生物药物中的核心产品,主要是通过基因工程菌来生产功能蛋白或其突变体,用于弥补体内蛋白的缺失,从而对疾病的治疗发挥关键作用。近年来,重组蛋白药物在疾病治疗中发挥作用越来越大,相关技术也发展迅速。通过综述重组蛋白药物的中上游生产流程,并重点分析了重组蛋白药物在表达系统、细胞培养、纯化和质量控制等环节的最新技术进展,展示了重组蛋白药物制备的技术提升水平,以期为国内重组蛋白药物的生产提供一定的参考依据。

Recombinant therapeutic proteins are the core products in biopharmaceuthc.They are mainly used to product functional proteins or their mutants by genethcally engineered bacteria to compensate for the loss of protenis in the body and play a key role in the treatment of diseases.In recent years,recombinant therapeutic proteins are playing an increasingly important role in the treatment of diseases,and related technologies are developing rapidly.The middle and upstream production process of recombinant therapeutic proteins was reviewed.The latest technological progress of recombinant therapeutic proteins in expression system,cell culture,purification and quality control was analyzed.The technological advances in the preparation of recombinant therapeutic proteins were demonstrated.It was expected to provide certain reference for domestic production of recombinant therapeutic proteins.