Batch testing and characterization
CER Groupe is equipped to characterize your biologics both regarding physico-chemical and activity parameters.Biologics characterization is critical to understanding the quality of the product and potential sources of variation in its activity.
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 interaction (biolayer interferometry, ELISA, CLIA, flow cytometry), purities/impurities (mass spectrometry, electrophoresis, chromatography, spectrophotometry), and activity (binding assays, cell-based assays, ELISPOT, in-vivo testing) characterization.
Test vaccines
We offer services to test vaccines, up to GMP quality standard. Indeed, vaccine characterization is subject to regulatory requirements, including the establishment or indication of vaccine potency.
This assay type, which is also sometimes monitored as an indicator of stability for a vaccine product, can be carried out in vitro or in vivo on a case-by-case basis.
Routine batch releases require a reliable partner as they are generally performed over extended periods of time and require both extreme rigor and a rapid turn-around time. With over 45 years of experience in this field, and our integrated immuno-monitoring platform, CER Groupe is your partner of choice for vaccine batch releases.
At CER Groupe, we offer batch-release services to industry for both human and veterinary vaccines. Our animal facilities are designed to handle various species, from rodents up to large animals, enabling the selection of the most appropriate host for the potency assay. Collected samples are then analyzed within our analytical platforms, generally through ELISA, ELISPOT or flow cytometry analyses.
Key figures
> 800 studies
> 12 species available
GLP certified since 1993