All biotherapeutics will need to undergo identification of antidrug antibodies sometime in their drug development life cycle. Immunogenicity is analyzed in a tiered approach where samples are first screened, then confirmed, and finally characterized through semi-quantitation (titer). Additional characterization such as domain specificity may also be required.
KCAS has developed immunogenicity assays (ADA assays) for a wide variety of biotherapeutics, including monoclonal antibodies, enzymes, and fusion proteins. Our scientists are skilled at acid disassociation methodology to detect antibodies in the presence of excess biotherapeutic. At KCAS, we have a wide variety of platforms to choose from which helps us to select the best platform to meet your immunogenicity detection needs.
KCAS has successfully developed and validated many ADA methods with sufficient drug tolerance to identify patients with both transient and persistent immune responses. We have a proven track record on developing and validating anti-drug antibody assays for support of clinical and non-clinical studies.