xPLOREing possibilities on the SMCxPRO^® platform: Development of an ultra-sensitive PK assay using custom assay services

WEBINAR

First in human (FIH) clinical trials of bispecific immunostimulatory antibodies commonly require a low starting dose based on a minimum anticipated biological effect level (MABEL) approach. To quantify serum drug concentrations at low dose levels, an ultrasensitive pharmacokinetic (PK) assay is required for Aptevo’s bispecific antibody, ADAPTIR-X. The SMCxPRO^® platform was identified as potentially having the capability to reach the required assay sensitivity. A feasibility assessment was undertaken utilizing the Custom Assay & Sample Testing (CAST) team and the custom assay development SMCxPLORE™ option, including testing of sensitivity, matrix effects, accuracy, and precision. From initial discussions to sample analysis, Aptevo and the SMC^® team efficiently collaborated to produce high quality, informative data, leading to the purchase and implementation of SMCxPRO^® technology at Aptevo. This presentation will introduce the CAST team and their in-house custom assay services, as well as describe the steps taken during the SMCxPLORE™ feasibility assessment to achieve a sensitivity of ~0.32 pg/mL for the ADAPTIR-X PK assay.

For Research Use Only. Not For Use In Diagnostic Procedures.

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