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.
Allison is a Principal Scientist at Aptevo Therapeutics in Seattle, WA, where she leads the Bioanalytical and Pharmacokinetics group. Her team focuses on the development of pharmacokinetic, immunogenicity, and biomarker assays for early preclinical to clinical stage support of ADAPTIR™ bispecific antibodies. Allison received a Master of Science degree in Cell Physiology from Case Western Reserve University in 2005. Prior to joining Aptevo, she was a Principal Scientist at Pfizer in La Jolla, CA in the BioMedicine Design department where she specialized in large molecule program management, bioanalytical assay development, and implementation of new technologies.
To continue reading please sign in or create an account.Don't Have An Account?