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Alternative method to isoenzyme assay
An alternative method for the isoenzyme method
IDENTIFICATION AND CHARACTERIZATION OF CELL LINES BY qPCR:
The classical method for cell line identity characterization is the isoenzyme assay. Clean Cells has developed and offers an alternative, innovative and relevant method to confirm cell line origin. Our test identifies a panel of 14 different* cell lines corresponding to the most currently used models in bioproduction with an increased sensitivity compared to the classical isoenzyme method. This method has been fully validated according to ICH Q2R1 guidelines and is available as ISO, GLP, or GMP grade.
Our business developers are available to provide you with additional information and send you the validation report upon request.
*14 species detected: human, mouse, rat, hamster, monkey (AGM), dog, cat, rabbit, horse, duck, chicken, beef, pig, Sp. frugiperda
Regulatory guidelines:
European Pharmacopoeia v6.5 § 5.2.3 Cell substrates for the production of vaccines for human use.
European Pharmacopoeia v6.5 § 5.2.4 Cell cultures for production of veterinary vaccines.
FDA, Points to consider in the manufacture and testing of monoclonal antibody products for human use. 1997.
FDA, Points to consider in the characterization of cell lines used to produce biologicals.