全风环保科技股份有限公司

目前，包括单抗、双抗、多抗治疗性蛋白药物已成为生物制药市场的主导产品类别之一。在制备这些治疗性蛋白药物时，单细胞克隆技术的应用对于确保产品质量的一致性和避免人为干预至关重要。通过有限稀释进行单细胞筛选耗时且低效，传统FACSta:image="" svg+xml,%3csvg="" width="'12'" height="'12'" viewbox="'0" 0="" 12="" 12'="" fill="'none'" xmlns="'http://www.w3.org/2000/svg'%3e%3cpath" fill-rule="'evenodd'" clip-rule="'evenodd'" d="'M7.60772" 8.29444c7.02144="" 8.73734="" 6.29139="" 9="" 5.5="" 9c3.567="" 2="" 7.433="" 5.5c2="" 3.567="" 2c7.433="" 5.5c9="" 6.28241="" 8.74327="" 7.00486="" 8.30946="" 7.5877c8.3183="" 7.59444="" 8.3268="" 7.60186="" 8.33488="" 7.60994l10.4331="" 9.70816l9.726="" 10.4153l7.62777="" 8.31704c7.62055="" 8.30983="" 7.61387="" 8.30228="" 7.60772="" 8.29444zm8="" 5.5c8="" 6.88071="" 8="" 8c4.11929="" 3="" 5.5c3="" 4.11929="" 3c6.88071="" 5.5z'="" style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; display: inline-block; vertical-align: super; font-size: 10px; width: 1.2em; height: 1.2em; -webkit-mask-position: 50% 50%; -webkit-mask-repeat: no-repeat; -webkit-mask-size: 100%; background-color: var(--weui-link); -webkit-mask-image: url(""); box-sizing: border-box !important; overflow-wrap: break-word !important;">技术昂贵的设备及人员培训又筑起了一道高门槛。

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阿斯利康对比了传统FACS与Namocell单细胞分离仪Pala, 结果表明与FACS衍生细胞系相比，Pala具有相当甚至更优的细胞生长和生产能力，且操作简单，运行/维护成本低，可以作为替代FACS更具性价比，高效便捷的选择。

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01

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试验方法

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1

将转染后的细胞进行荧光标记，通过FACS和单细胞分离仪Pala将单细胞分离至384孔板中

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2

 对分配后的细胞进行成像和克隆生长评估，以确定单细胞克隆的成功率。

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3

 通过小规模补料分批培养评估不同克隆来源的细胞系的生长特性和生产能力。

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02

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研究结果

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1

Pala 的单细胞分离效率高达96.3%，细胞活率高，生长2周后无空孔

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2

在易于表达的单克隆抗体和不易于表达的非单克隆抗体模型中，对于生长状况和产量滴度来说，FACS和Pala无明显差异。

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3

在两种模型中，无论是滴度、Qp、分裂速率、z大细胞密度、活率均无明显差异。

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4

Pala与FACS相比，机器小巧轻便可放置在安全柜中，易于无菌操作。开机校准时间短、关机流程简单迅速、鞘液ta:image="" svg+xml,%3csvg="" width="'12'" height="'12'" viewbox="'0" 0="" 12="" 12'="" fill="'none'" xmlns="'http://www.w3.org/2000/svg'%3e%3cpath" fill-rule="'evenodd'" clip-rule="'evenodd'" d="'M7.60772" 8.29444c7.02144="" 8.73734="" 6.29139="" 9="" 5.5="" 9c3.567="" 2="" 7.433="" 5.5c2="" 3.567="" 2c7.433="" 5.5c9="" 6.28241="" 8.74327="" 7.00486="" 8.30946="" 7.5877c8.3183="" 7.59444="" 8.3268="" 7.60186="" 8.33488="" 7.60994l10.4331="" 9.70816l9.726="" 10.4153l7.62777="" 8.31704c7.62055="" 8.30983="" 7.61387="" 8.30228="" 7.60772="" 8.29444zm8="" 5.5c8="" 6.88071="" 8="" 8c4.11929="" 3="" 5.5c3="" 4.11929="" 3c6.88071="" 5.5z'="" style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; display: inline-block; vertical-align: super; font-size: 10px; width: 1.2em; height: 1.2em; -webkit-mask-position: 50% 50%; -webkit-mask-repeat: no-repeat; -webkit-mask-size: 100%; background-color: var(--weui-link); -webkit-mask-image: url(""); box-sizing: border-box !important; overflow-wrap: break-word !important;">消耗更少、耗材成本低、易于终端用户操作、仪器维护成本更低。

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单细胞分离仪Pala结合微流控技术ta:image="" svg+xml,%3csvg="" width="'12'" height="'12'" viewbox="'0" 0="" 12="" 12'="" fill="'none'" xmlns="'http://www.w3.org/2000/svg'%3e%3cpath" fill-rule="'evenodd'" clip-rule="'evenodd'" d="'M7.60772" 8.29444c7.02144="" 8.73734="" 6.29139="" 9="" 5.5="" 9c3.567="" 2="" 7.433="" 5.5c2="" 3.567="" 2c7.433="" 5.5c9="" 6.28241="" 8.74327="" 7.00486="" 8.30946="" 7.5877c8.3183="" 7.59444="" 8.3268="" 7.60186="" 8.33488="" 7.60994l10.4331="" 9.70816l9.726="" 10.4153l7.62777="" 8.31704c7.62055="" 8.30983="" 7.61387="" 8.30228="" 7.60772="" 8.29444zm8="" 5.5c8="" 6.88071="" 8="" 8c4.11929="" 3="" 5.5c3="" 4.11929="" 3c6.88071="" 5.5z'="" style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; display: inline-block; vertical-align: super; font-size: 10px; width: 1.2em; height: 1.2em; -webkit-mask-position: 50% 50%; -webkit-mask-repeat: no-repeat; -webkit-mask-size: 100%; background-color: var(--weui-link); -webkit-mask-image: url(""); box-sizing: border-box !important; overflow-wrap: break-word !important;">、流式细胞术和液滴分配技术，在＜2psi的低压下对细胞进行分选，可分别在1分钟和6分钟内将细胞分选到96或384孔板中。在节省大量分选时间的同时获得健康且有活力的细胞。

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Pala保证了较高的单细胞效率，单细胞入孔率超过90%。自动化设计使得操作简单直观，不需要专门的操作人员和大量的应用培训。小巧轻便的设计允许其可以在超净台内完成操作，一次性细胞芯片避免了样本间的交叉污染。

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