BioReliance CRO’s cell line characterization services enable production of biologicals free of molecular, cellular, and viral contamination. We offer a wide variety of cell line characterization services including:
We suggest performing cell line characterization studies on both mammalian and non-mammalian cell lines for our customers in various stages of drug production including:
Custom services also are available. Contact BioReliance and our research team will be happy to assist you in planning your cell line characterization studies. Below you will find more information about the regulatory guidelines we support.
Regulatory Guidelines for Cell Characterization
BioReliance CRO scientists will assist you in designing your cell line characterization studies in compliance with global current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) practices as well as FDA and international regulatory guidelines.
The regulatory requirements for a cell line or virus seed characterization program have three major components:
If the product is to be marketed internationally, then initial efforts should be placed on developing cell line characterization and testing programs that satisfy regulatory requirements and recommendations of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japanese Ministry of Health, Labour and Welfare.
BioReliance has manufactured and characterized hundreds of client cell banks and offers a complete testing program. Programs are custom designed to take into account the species of origin and culture history of the cells. Click here to contact us for your cell line characterization needs.
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