Biologic testing and characterization

Biological characterization is critical for understanding the quality of the product and potential sources of variation in their activity.

Whatever the aim of the biologic is to be incorporated into a diagnostic assay or for therapeutic hit/lead development, the understanding of its physico-chemical, structural and activity properties is important and critical at some point. For example, it is well known that biologic integrity can have a direct effect on its sensitivity, specificity and stability, or that product or process-based impurities can impact hit efficacy, immunogenicity or induce inflammation.

Fine characterization of glycan profile and distribution is another example of critical characterization for therapeutic antibodies or reagents used for advanced conjugation strategies.

Finally, regarding the biologic manufacturing, the characterization of product quality attributes is important for process development, validation and routine control.

At CER Groupe, we are equipped to characterize your biological products in terms of both physico-chemical and activity parameters.

Thanks to our comprehensive platform, we can evaluate molecular interactions (biolayer interferometry, ELISA, CLIA, flow cytometry), purities/impurities (mass spectrometry, electrophoresis, chromatography, spectrophotometry), and activity (binding assays, cell-based assays, ELISPOT, in-vivo testing) profiles.

Our teams are committed to deliver robust results for punctual or routine analyses, from research to commercial projects, with the validation level tailored to your needs. Next to our extended routine methods, we also propose fully custom strategies to support your project.

CASE STUDY

Characterization of a therapeutic candidate mAb against SARS-CoV-2 Spike RBD that was developed in-house.

During the COVID-19 crisis, tremendous efforts were put in all around the world to rapidly develop diagnostic and therapeutic solutions for public health management.

DISCOVER OUR CASE STUDY