Cell lines/strains themselves may carry pathogenic microorganisms such as bacteria, mycoplasma, mycobacterium, endogenous viruses and viruses contaminated by the outside world.
If the cell matrix is contaminated by pathogenic microorganisms such as viruses, the biological products produced will also contain contaminated pathogenic microorganisms, which directly affects the safety of the products.
Therefore, after the establishment of the primary cell bank (PCB), the master cell bank (MCB) and the working cell bank (WCB), the harvesting of End of Product Cells (EOPC) and the harvesting of the harvesting solution all require cell verification.
1.determine the detection scheme 2.sign a contract to pay for services 3.send experimental materials 4.experimental testing 5.result analysis and test report
In the case of MCB, WCB and 3 batches of EOPC, the detection can be completed in 4-6 months.
The method is mature and has been rigorously validated by methodology.
Several cell bank items such as CHO and 293 have been successfully detected.
Provide technical guidance throughout the project, and can provide a variety of related consultation before the project is launched.
The staff has rich experience, including many doctors, masters and excellent experimental operators.
We have a profound understanding of the current requirements and future trends of China's FDA, US FDA and ICH, and we will provide the best cell bank testing program according to our customers'products.
Cell verification mainly includes the following aspects: cell identification, aseptic examination, Mycoplasma examination, endogenous and exogenous virus contamination examination, chromosome examination, tumorigenicity examination, tumorigenicity examination, etc. The basic requirements of cell verification are as follows:
|examination of bacteria and fungi||+||+||+|
|detection of endogenous and exogenous virus contamination||observation of cell morphology and blood adsorption test||+||+||+|
|inoculation and culture of different indicator cells in vitro||+||+||+|
|in vivo inoculation of animal and chicken embryos||+||-||+|
|genus-specific exogenous virus||(+)||-||-|
|bovine-derived virus test||(+)||(+)||(+)|
|swine origin virus examination||(+)||(+)||(+)|
|examination of other specific viruses||(+)||(+)||(+)|
|chromosome examination (human diploid cell line)||(+)||(+)||(+)|
|Note: "+" is a compulsory item, and "-" is a non-compulsory item. (+) Indicates the required verification items according to cell characteristics, passage history, culture process, etc.|
viral clearance validation service
endotoxin removal related
stable cell line development service