Leveraging single‐pass tangential flow filtration to enable decoupling of upstream and downstream monoclonal antibody processing
Leveraging single‐pass tangential flow filtration to enable decoupling of upstream and downstream monoclonal antibody processing
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利用单通道切向流过滤实现上游和下游单克隆抗体处理的分离
DOI：
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
M. Westoby
中科院分区：
文献类型：
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作者：
Alex Brinkmann;Sanaa Elouafiq;John Pieracci;M. Westoby
生物制药生产的上下游业务分离可以实现更灵活的生产操作，并可以使公司利用否则无法实现的战略或财务利益。开发并扩大了去耦过程，利用单道切向流过滤来减少体积，然后在纯化之前在一次性袋中进行大量冷冻。单道切向流过滤可用于连续浓缩收获的细胞培养液，将体积减少15 - 25倍，一步产量为>96%。这些浓度因子在第二种产品中重现，表明该工艺可以适用于平台工艺。实验数据表明，所测产品在- 40或- 70°C下至少稳定一年。收获的细胞培养液的浓度——无论是否有后续的冷冻储存——对测试的产品质量属性没有影响。©2018美国化学工程师协会生物技术。掠夺。中文信息学报，34 (4):405 - 411,2018
Decoupling upstream and downstream operations in biopharmaceutical production could enable more flexible manufacturing operations and could allow companies to leverage strategic or financial benefits that would be otherwise unattainable. A decoupling process was developed and scaled up utilizing single‐pass tangential flow filtration for volume reduction, followed by bulk freezing in single‐use bags prior to purification. Single‐pass tangential flow filtration can be used to continuously concentrate harvested cell culture fluid, reducing the volume by 15‐25× with a step yield of >96%. These concentration factors were reproduced with a second product, indicating that the process could be amenable to platform processes. Experimental data indicate that the product tested was stable for at least one year at −40 or −70°C. The concentration of the harvested cell culture fluid—either with or without a subsequent period of frozen storage—had no impact on the product quality attributes that were tested. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 34:405–411, 2018