摘要
目的:目标单抗在超滤渗滤过程中易产生不溶性颗粒,堵塞膜包,使膜包通量降低,换液无法顺利进行,因此要控制超滤渗滤步骤中不溶性颗粒的产生,完成蛋白质浓缩换液过程。方法:通过比较不同缓冲液体系、不同添加剂、是否进行搅拌找出不溶性颗粒产生的原因和控制方法。结果:不溶性颗粒的产生与缓冲液体系无关,而与搅拌有关;在超滤渗滤进行时,必须使用搅拌来保证样品的均一性;加入吐温可有效控制不溶性颗粒的产生。结论:大部分的单抗处方中,吐温均会作为一种表面活性剂加入,本研究最终采用提前加入吐温方式,使超滤渗滤正常运行。
Objective:The target monoclonal antibody(mAb)in this study was prone to produce particles during ultrafiltration/diafiltration(UF/DF),and then block the UF/DF membrane,decrease the UF/DF permeate flux.TheUF/DF can’t complete successfully.The objective of this study was to control the paticle formation during UF/DF,making UF/DF complete smoothly.Mehtod:The causes and control methods of particles were found by comparing different buffer systems,different additives and agitation.Results:The formation of insoluble particles has no related with buffer system but with agitation.But agitation was necessary in UF/DF process.Adding tween in UF/DF sample can control particle formation.Conclusion:In most monoclonal antibody prescriptions,tween is added as a surfactant.In this study,tween is added in advance to ensure the normal operation of ultrafiltration.
作者
罗映
贺芸芬
刘建平
Luo Ying;He Yun-fen;Liu Jian-ping(Shanghai OPM BiosciencesCo.,Ltd.,Shanghai201318;School of life sciences,ShanghaiFudan University,Shanghai200433)
出处
《生物化工》
2020年第3期32-35,共4页
Biological Chemical Engineering
关键词
单抗
纯化工艺
超滤渗滤
不溶性颗粒产生
Monoclonal antibody
Purification process
Ultrafiltration/diafiltration
Particle formation
