New York Blood Center, New York, New York, USA.
Curr Opin Hematol. 2020 Nov;27(6):415-422. doi: 10.1097/MOH.0000000000000611.
A critical common step for blood-based ex-vivo gene and immune effector cell (IEC) therapies is the collection of target cells for further processing and manufacturing, often accomplished through a leukapheresis procedure to collect mononuclear cells (MNCs). The purpose of this review is to describe strategies to optimize the apheresis product cell yield and purity for gene and IEC therapies. Relevant data from the conventional bone marrow transplant literature is described where applicable.
Product yield is affected by three main factors: the peripheral blood concentration of the target cell, optimized by mobilizing agents, donor interventions or donor selection; the volume of peripheral blood processed, tailored to the desired product yield using prediction algorithms; and target cell collection efficiency, optimized by a variety of device and donor-specific considerations. Factors affecting product purity include characteristics of the donor, mobilizing agent, device, and device settings.
Strategies to optimize product yield and purity for gene and IEC therapies are important to consider because of loss of target cell numbers or function with downstream steps and detrimental effects of nontarget cells on further manufacturing and patient outcome.
血液来源的基因和免疫效应细胞（IEC）疗法的一个关键共同步骤是收集靶细胞进行进一步的处理和制造，通常通过白细胞分离术来收集单核细胞（MNC）来完成。本综述的目的是描述优化基因和 IEC 疗法的吸附产物细胞产量和纯度的策略。在适用的情况下，描述了来自常规骨髓移植文献的相关数据。
产物产量受三个主要因素的影响：目标细胞的外周血浓度，通过动员剂、供者干预或供者选择来优化；处理的外周血体积，根据所需的产物产量使用预测算法进行调整；以及目标细胞的收集效率，通过各种设备和供者特异性考虑因素进行优化。影响产物纯度的因素包括供者、动员剂、设备和设备设置的特点。
优化基因和 IEC 疗法的产物产量和纯度的策略很重要，因为下游步骤会导致靶细胞数量或功能的损失，并且非靶细胞对进一步的制造和患者结果有不利影响。
