Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug tolerance. The method uses acid disassociation of ADA-therapeutic interaction. This allows for preferential capture of ADA by an immobilized version of the dosed therapeutic. A second disassociation step used to enable selective transfer of treated sample to an MSD bridging assay. Following the ACE procedure this assay utilizes biotinylated and ruthenium labeled drug to detect antidrug antibodies.
Successful Development of Affinity Capture Elution Methods
KCAS has experience in a variety of different sample preparation techniques to improve detection of ADA in the presence of therapeutic. Additionally, this includes the use of Affinity Capture Elution (ACE). Our scientists are skilled at optimizing the acid/neutralization steps. This assures low affinity binding antibodies are able to be captured and detected in unknown samples. Moreover, KCAS has deep experience in developing drug tolerant methods using both bead based and plate based assay formats.
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 acid disassociation methods to detect anti-drug antibodies earlier than the terminal phase of a pharmacokinetic profile.