生物大分子药物生产工艺技术转移关键点探讨

Exploring the Key Points of Technology Transfer for Production Process of Biological Macromolecules

技术转移贯穿于生物大分子药物的整个生命周期。考虑到生物大分子药物结构的复杂性及生产的不可控性,该文将生物大分子药物的生产工艺技术转移分为临床前和早期临床样品生产,以及关键性临床和商业化阶段样品生产2个阶段,分别进行探讨。根据每个阶段的目标任务,从细胞株、原材料、生产工艺、外源因子安全性评价以及可比性研究等方面细化生产工艺技术转移的关键控制点,据此提出相对应的技术转移策略,并列举了生物大分子药物技术转移过程当中经常遇到的问题,以期为生物制药企业进行生产工艺技术转移提供参考。

Technology transfer is crucial throughout the entire lifecycle of biological macromolecules.Given the intricate structure and the unpredictable production of biological macromolecules,this review categorizes the technology transfer of production process of biological macromolecules into two phases:preclinical and early clinical sample production,as well as pivotal clinical and commercialization stage sample production.Depending on the objectives and tasks of each phase,key control points for technology transfer in production processes,encompassing cell lines,raw materials,production processes,safety evaluation of exogenous factors,and comparability studies,are identified.And the corresponding technology transfer strategies are suggested,accompanied by a compilation of common challenges faced during the technology transfer process of biological macromolecules,with the aim to serve as a guide for biopharmaceutical companies in their technology transfer for production process.