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首页> 外文期刊>Biotechnology Progress >Clearance of solvents and small molecule impurities in antibody drug conjugates via ultrafiltration and diafiltration operation
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Clearance of solvents and small molecule impurities in antibody drug conjugates via ultrafiltration and diafiltration operation

机译：通过超滤和渗滤操作清除抗体药物缀合物中的溶剂和小分子杂质

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摘要

Ultrafiltration and diafiltration (UF/DF) processes by tangential flow filtration (TFF) are frequently used for removal of solvents and small molecule impurities and for buffer exchange for biopharmaceutical products. Antibody-drug conjugates (ADCs) as an important class of biological therapeutics, carry unique solvents and small molecule impurities into the final UF/DF step as compared to standard antibody preparation. The production process of ADCs involves multiple chemical steps, for example, reduction and conjugation. The clearance of these solvents and small molecules by UF/DF, specifically the DF step, has been assessed and described herein. The rates of clearance for all the impurities in this study are close to the ideal clearance with no apparent interaction with either the protein or the TFF membrane and system. The effect of process variables during DF, such as pH, temperature, membrane loading, transmembrane pressure, and cross flow rate, has also been evaluated and found to have minimal impact on the clearance rate. These results demonstrate efficient clearance of solvents and small molecule impurities related to the ADC process by the DF process and provide a general data package to facilitate risk assessments based on the sieving factors and program specific needs.
机译：通过切向流动过滤（TFF）的超滤和渗滤（UF / DF）方法经常用于去除溶剂和小分子杂质，并用于生物制药产品的缓冲换双。与标准抗体制剂相比，抗体 - 药物缀合物（ADC）作为一种重要的生物治疗，将独特的溶剂和小分子杂质携带到最终的UF / DF步骤中。 ADC的生产过程涉及多种化学步骤，例如减少和缀合。本文已经评估和描述了通过UF / DF，特别是DF步骤的这些溶剂和小分子的间隙。本研究中所有杂质的间隙率接近理想间隙，没有明显相互作用与蛋白质或TFF膜和系统。还评估了DF期间工艺变量在DF期间的影响，也已经评估了PH，温度，膜负荷，跨膜压力和交叉流速，并发现对所述间隙率的影响最小。这些结果表明，DF工艺证明了与ADC工艺相关的溶剂和小分子杂质的有效间隙，并提供了一般数据包，以促进基于筛分因素和方案特定需求的风险评估。

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