Q.C testing – Product characterization
For gene and cell therapy treatments and antibodies based treatment approaches; GenoSafe has unique expertise in the quality control of preclinical and clinical batches.
Our research managers work in close collaboration with the Quality Assurance department to be able to provide a Certificate of Analysis.
Our areas of expertise
Adeno-Associated Viral vectors (AAV)
Non integrative Lentiviral vectors
Cells with CRISPR modifications
Stem Cells (Differenciated)
Autologous modified cells
Our main services
We advise and assist our clients in fulfilling their testing needs (in accordance with the European Pharmacopoeia and the FDA/USP guidelines) including the development of specific assays that address challenges encountered during the the design and production of their therapeutic products.
Development, qualification and validation of analytical methods
Product Testing and Characterization
Detection of replication-competent viruses
Purity: Detection of specific contaminants
Potency/Efficacy: Customized assays, enzymatic assays, expression assays
Cell line characterization
We’ll foster a flexible approach and open communication with you and the product manufacturer (whether based in Europe or in the USA).