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Evaluation of single-use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing
Biotechnology Progress ( IF 2.9 ) Pub Date : 2021-08-30 , DOI: 10.1002/btpr.3204
Seyed Pouria Motevalian 1 , Jonathan Steen 2 , Janine De Leon 1 , Verl Sriskanda 3 , Ivette Carino 1 , Amar S Prashad 1 , Brenda Carrillo Conde 4 , Bo Arve 4
Affiliation  

Over the past decade, single-use tangential flow filtration (TFF) technologies have emerged to reduce system preparation time, promote fast and flexible product change over, and ultimately shorten process development and manufacturing time/cost. In this study, the performance of a recently developed Pellicon® single-use TFF capsule was compared against traditional Pellicon® cassettes by assessing TFF process performance (such as flux, residuals clearance, and yield) and post-purification product attributes (such as concentration and mass-weighted average molecular weight). Good scaling was shown by comparing process performance and product attributes across different scales and formats. Additionally, similar TFF process performance and post-purification product attributes were observed for the single-use capsule compared to the reusable TFF cassettes. The capsule requires a smaller flush than the cassette, and it is easier to use since it does not require a compression holder or pre-sanitization. The results provide insight into the application of the single-use TFF capsule and scalability of TFF processes for the purification of conjugate vaccines.

中文翻译:

用于纯化结合疫苗生产中使用的活化多糖的一次性切向流过滤技术的评价

在过去十年中,出现了一次性切向流过滤 (TFF) 技术,以减少系统准备时间,促进快速灵活的产品更换,并最终缩短工艺开发和制造时间/成本。在这项研究中,通过评估 TFF 工艺性能(如通量、残留物清除率和产量)和纯化后产品属性(如浓度和质量加权平均分子量)。通过比较不同规模和格式的工艺性能和产品属性,显示出良好的缩放比例。此外,与可重复使用的 TFF 盒相比,一次性胶囊的 TFF 工艺性能和纯化后产品属性相似。胶囊需要比盒子更小的冲洗量,并且更容易使用,因为它不需要压缩支架或预消毒。结果提供了对一次性 TFF 胶囊的应用和 TFF 工艺在结合疫苗纯化中的可扩展性的深入了解。
更新日期:2021-08-30
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