Exploring the Key Points of Technology Transfer for Production Process of Biological Macromolecules
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.
biological macromoleculeproduction processtechnology transferkey control point
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