黑胶虫常见问题



黑胶虫常见问题



BI 血清生产完全符合 cGMP 的生产要求,并通过 ISO13485: 2003 和 ISO9001: 2008 质量认证,符合 USDA 标准,具有欧洲药品监督管理局颁发的 EDQM 证书。每个批次均通过严格质量控制和多种细胞培养测试,产品拥有可靠质量和卓越表现。


问题一

黑胶虫是什么?

对于细胞培养中存在的“黑胶虫”问题,目前学术界尚无明确的定论。国外学者一般将其称之为“纳米细菌(Nanobacteria,NB)“或”钙化性纳米颗粒(Calcifying nanoparticles,CNP)“[1-17]。随着后续研究的深入,其生物学特性依然存在多方面的争议 [13; 18-28]


对于极个别客户反馈的“黑胶虫”问题,我们十分重视。通过分析客户寄回的“黑胶虫”样本(见 Figure 1),我们发现其物理直径为 0.75 ± 0.15 μm,这远超我们的血清过滤尺寸(0.1 μm 过滤,3次)。因此,该“黑胶虫”不可能源自 BI 血清产品。


解决方案:

在分析客户寄回的“黑胶虫”污染样本时,持续两周使用 Biomyc(BI:03-038)和三抗(BI:03-032),发现可杀灭该“黑胶虫”污染。


Figure 1. 显微镜下观察到的“黑胶虫”样本,直径约为 1μm。



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