Characterization of mammalian cell lines used in the production of biopharmaceuticals requires technical expertise across a wide range of biological disciplines. Alpha Lifetech Inc.'s team can consult with you to determine a testing protocol that will stand up to regulatory scrutiny, while providing you with a program that is also cost-effective.
Cell Line Service – Validation of Stable Cell lines
To create reliable cell lines, Alpha Lifetech Inc. has developed a platform to validate the state of cell lines, including identity, growth morphology, genetic stability, tumorigenicity, sterility general virus screening, species-specific virus tests, retrovirus tests and adventitious agents from raw material. We offer you various methods from Virology, Microbiology, Cell Biology and Molecular Biology, and knowledge in-deep understanding of vaccine development to validate the state of your cell line.
For example, Short Tandem Repeat (STR), a short repeat sequence consisting of 3~7 bp, can be used as a marker to identify the relationship between filial generation and parent generation through PCR amplification technology. The alleles at the STR locus can be distinguished by the number of copies of the STRs within the amplified region, which can be identified by fluorescence detection after capillary electrophoresis separation.
Service Features of Validation of Stable Cell lines
-- > 100 human and animal viral PCR probes
-- >60 human and animal cell lines for control
-- Custom assays developed for unique cell lines as needed
-- Expert advice/consulting on worldwide regulatory requirements
Besides, Alpha Lifetech Inc. provides our clients with gene editing (gene knock-out/in) and cell knockdown services. By knocking down proteins of interest, we have created a series of stable and low-expressed cell lines. If you have any questions, please feel free to contact us at any time.