连续流层析及用于抗体分离的新进展

Progress on continuous chromatography and its application in antibody separation

连续生物制造是生物制药的发展趋势,其中连续流层析是关键环节。作者根据近年来国内外连续流层析的研究进展,着重介绍了产物捕获和精制阶段的连续流层析技术,分析了不同模式的技术差异、各自特点和应用现状。针对未来发展趋势,进一步介绍了整合连续流层析过程,以及用于抗体连续生产的难点和挑战。作为一项新兴技术,抗体连续生产具有提高过程产率和产品质量、促进设备小型化和流程自动化、拓展过程灵活性和可靠性、降低生产成本等显著优势,但尚有不少方面需要改进和深化,包括过程设计、过程分析技术和过程控制技术等,特别是基于模型的预测分析和控制方法。

Continuous chromatography is a key unit of continuous biomanufacturing which is the trend in biopharmaceutical industry.The continuous chromatographic technologies for protein capture and polishing were reviewed based on recent research progress.Technical differences,characteristics and current applications of different separation modes are focused.Integrated continuous chromatography is introduced and the challenges for continuous production of antibodies are discussed considering future development.Continuous manufacturing has the potentials to increase productivity and product quality,reduce footprint and costs,and enhance process automatization,flexibility and reliability.However,more studies such as process design,process analytical and control technologies,are necessary to improve continuous manufacturing processes,especially for model-based predictive analysis and control strategies.