Our Product Characterization services offering combines mAb physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug—its critical quality attributes. All testing is performed in a GMP qualified laboratory and is compliant with ICH guidelines, FDA, and EMA regulations.
Assays are available to suit your development phase, including:
- Early material from stable pools or stable cell lines
- Clone selection
- Final clone testing
- Research or master cell bank