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.

AAV, Lentivirus, Plasmid, CRISPR, CarT Cells

Our areas of expertise

Adeno-Associated Viral vectors (AAV)
Lentiviral vectors
Non integrative Lentiviral vectors
Retroviral vectors
Car-T cells
Cells with CRISPR modifications
Plasmid
Stem Cells (Differenciated)
Autologous modified cells
Monoclonal Antibodies
Bacteria

 

 

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

Viral Titration

Detection of replication-competent viruses

Purity: Detection of specific contaminants

Potency/Efficacy: Customized assays, enzymatic assays, expression assays

Cytotoxicity

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).