珈创生物 —— 生物技术服务与研发为一体的高新技术企业
优质高效透明
High quality, efficient and transparent
To ensure compliance to the regulations and guidelines by Chinese Pharmacopoeia (ChP), National Medical Products Administration (NMPA), Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), and International Conference on Harmonization (ICH), cell lines are validated for their origins and passaging history, verified for their identities, and determined for their stability and purity.
The cell testing service consists of Cell Characterization Tests, Sterility Testing, Mycoplasma Testing, Cell Endogenous / Exogenous Viral Agent Detection, Tumor Test/ Carcinogenicity Test, etc. We utilize multiple testing systems and characterization methods for each category.
These tests are applicable to MCB cells, WCB cells, and passaging limited production cells. We recommend that comprehensive testing should be performed on the mammalian and the non-mammalian cells, including their Master Cell Bank (MCB), Working Cell Bank (WCB), End of Production Cells (EOPC), Virus Seed Source (VSS), source cells, and end product cells in every drug manufacturing stage.
We have evaluated cell banks, raw materials, and cell derivatives such as therapeutic products for our domestic and international clients.
All tests and services can be tailored to our client's specific needs. Please inquire.