收据和扩展

收到后，为跟踪目的分配所有单元格号。细胞系被转移到其在培养中生长并扩展以产生细胞库的检疫区域。

MAP Testing and cell storage

地图测试is performed on the cell stock. Our standard MAP panel tests for 19 murine adventitious agents, including mycoplasma. Testing is completed in approximately six weeks. After MAP testing, the cell stock is stored in a cGMP, alarmed, cryogenic tank for future runs.

Optimization and inoculation

Envigo offers a unique approach to research optimization for large-scale production. This involves performing a dosage study to determine time frames for ascites production development, mortality, incidence of solid tumors, volume of ascites, and concentration of immunoglobulin.

优化节省时间并允许最大单克隆抗体产量。客户可以在大规模生产之前用于分析腹水。

As for your cost concerns? This unique service is provided at no additional cost for production runs of greater than 100 mice. Optimizations are available for smaller runs at an additional cost.

Production

通过地图测试和优化完成，在CGMP指南下发起生产。在生产过程中，在所有要点实行完整的线路间隙。

Harvest

在湿冰上收集腹水并离心以去除细胞和脂质材料。将澄清的腹水置于无菌容器中，标记并立即冷冻。

Quality control

最终产品的质量控制可包括特异性亚类RID以确定ELISA和内毒素检测的免疫球蛋白浓度，USP无菌试验，9CFR无菌试验和测定特定活动的测定。最终腹水在-25°C或-70°C处冻结，直到它已准备好装运。

腹水生产用于研究使用

研究的腹水生产包括与CGMP相同的阶段，然而，不包括对细胞系的地图测试，从而降低了成本并降低了周转时间。我们的技术人员将向您提供各阶段的生产。如果您需要它，我们的协议可以自定义以满足您所需的规格。