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首页> 外文期刊>Biotechnology Progress >Streamlining process characterization efforts using the high throughput ambr (R) crossflow system for ultrafiltration and diafiltration processing of monoclonal antibodies
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Streamlining process characterization efforts using the high throughput ambr (R) crossflow system for ultrafiltration and diafiltration processing of monoclonal antibodies

机译：简化使用高通量AMBRCrossflow系统进行单克隆抗体的高通量AMBRCrossflow系统的工艺表征工作

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Commercial process development for biopharmaceuticals often involves process characterization (PC) studies to gain process knowledge and understanding in preparation for process validation. One common approach to conduct PC activities is by using design-of-experiment, which can help determine the impact process parameter deviations may have on product quality attributes. Qualified scale-down systems are typically used to conduct these studies. For an ultrafiltration/diafiltration (UF/DF) application, however, a traditional scale-down still requires hundreds of milliliters of material per run and can only conduct one experiment at a time. This poses a challenge in resources as there could be 20+ experiments required for a typical UF/DF PC study. One solution to circumvent this is the use of high-throughput systems, which enable parallel experimentation by only using a fraction of the resources. Sartorius Stedim Biotech has recently commercialized the ambr (R) crossflow high-throughput system to meet this need. In this study, the performance of this system during a monoclonal antibody UF/DF step was first compared with a pilot- and a manufacturing-scale tangential flow filtration (TFF) system at a single operating condition. Due to material limitations, it was then compared to only the pilot-scale TFF system across wider ranges of transmembrane pressure; crossflow rate; and diafiltration concentration in a PC study. Permeate flux, aggregate content, process yield, pH/conductivity traces, retentate concentration, axial pressure drop, and turbidity values were measured at both scales. A good agreement was attained across scales, further supporting its potential use as a scale-down system.
机译：生物制药的商业流程开发往往涉及过程表征（PC）研究，以获得过程知识和理解以准备进程验证。进行PC活动的一种常见方法是通过使用实验设计，可以帮助确定影响过程参数偏差可能对产品质量属性具有。合格的缩放系统通常用于进行这些研究。然而，对于超滤/渗滤（UF / DF）应用，传统的缩放仍然需要每次运行数百毫升的材料，并且只能一次进行一个实验。这在资源中提出了挑战，因为典型的UF / DF PC研究需要有20多个实验。一个规避这一点的解决方案是使用高吞吐量系统，该系统仅通过使用一小部分来实现平行实验。 Sartorius Stedim Biotech最近商业化了AMBR（R）Crossflow高吞吐量系统，以满足这种需求。在该研究中，首先与单克隆抗体UF / DF步骤在单克隆抗体UF / DF步骤中的性能与在单个操作条件下的试验和制造级切向流过滤（TFF）系统相比。由于材料限制，然后仅与跨越跨膜压力范围的导频尺度TFF系统进行比较;跨流量; PC研究中的渗滤浓度。在两个尺度上测量渗透剂通量，骨料含量，工艺产率，pH /电导率痕迹，滞留物浓度，轴向压降和浊度值。尺度达到了良好的协议，进一步支持其潜在用途作为缩放系统。

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