Quality cannot be compromised in the face of accelerated R&D. To validate the high quality of cell drugs, we provide an established characterization and validation services based on the FDA guideline, which lists required analysis, and United States Pharmacopeia (USP) that specifies the validation methods. These services include detection of impurities, microbiological tests, tumorigenicity tests, and so on.

Impurity Examination Residual FBS Residual bFGF Residual TrypLE Residual Gentamicin Residual Collagenase NB6 Residual DMSO Microbiological Testing Mycoplasma PCR Endotoxin testing CMV & HHV 6, 7, 8 detection In Vitro Tumorigenicity

Contact Us

E-mail：contract_service@meridigen.com

Tel：02-2627-5175