ABSTRACT

Membrane adsorbers (MA) are emerging as alternative unit operations in high-value protein separation due to their many benefits, including short residence times, low pressure drop, ease of scale-up and cost-effectiveness. Historically, the MA literature has been directed to new membrane materials and their use as a polishing step due to their low binding capacity. More recently, the emergence of membrane bind-elute modalities has extended their application at industrial scale, and a move from established resin chromatography to MA is feasible. To fill this gap and speed the development of MA, a review on the purification of monoclonal antibodies and other proteins in the pharmaceutical and food industries using commercially available MA and resin chromatography devices is presented. We compare MA with resins using three key criteria: product quality, industrial process feasibility and economic viability. In most studies, MA can produce comparable or even better product quality than resin chromatography. MA can be applied for multiple cycles within a single batch before disposal, leading to high productivity, savings from buffer consumption and the omission of cleaning verification. A cost analysis concludes that this approach can be more economical than resin chromatography.

摘要

膜吸附器 (MA) 因其许多优点而成为高价值蛋白质分离中的替代单元操作，包括停留时间短、压降低、易于扩大规模和成本效益。从历史上看，MA 文献一直针对新的膜材料以及由于其低结合能力而将其用作抛光步骤。最近，膜结合洗脱模式的出现扩展了其在工业规模的应用，并且从已建立的树脂色谱法转向 MA 是可行的。为了填补这一空白并加速 MA 的发展，本文对制药和食品行业中使用市售的 MA 和树脂层析设备纯化单克隆抗体和其他蛋白质进行了综述。我们使用三个关键标准将 MA 与树脂进行比较：产品质量、工业流程可行性和经济可行性。在大多数研究中，MA 可以产生与树脂色谱相当甚至更好的产品质量。MA 可在处置前在单批次内应用多个周期，从而提高生产率、节省缓冲液消耗并省略清洁验证。成本分析得出的结论是，这种方法比树脂色谱法更经济。