[BEBPA 2019] Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, & Ranibizumab

[BEBPA 2019] Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, & Ranibizumab
File Name/Number:
BEBPA 2019

Year:
2019


Cell-based bioassays often pose a hurdle during a rapidly moving biologics development program. High standards for assay accuracy, precision, reproducibility, and robustness are additionally put to the test by the use of continuous culture cells that can add to variability and increase the cost and complexity of each assay. This is particularly challenging for anti-VEGF drugs, as the prevalent assay is the proliferation of human umbilical vein endothelial
cells (HUVECs), which requires 72-96 hours to run, utilizes primary cells that are difficult to culture and introduces performance variability due to changes in donor, passage number, culture conditions, and analyst.

Here, we describe a PathHunter® bioassay that has been developed as a fit-for-purpose potency & stability assay for anti-VEGF drugs. The assay quantifies inhibition of VEGF-A-induced VEGFR2 receptor activation, by measuring an early event in the receptor activation cascade. With its shorter assay time (<24 hours), simple ‘add and read’ protocol, and use of cryopreserved ready-to-assay cells, the PathHunter assay has many advantages over the standard HUVEC assay. Qualification data will be presented on the performance of the PathHunter bioassay for bevacizumab, aflibercept, and ranibizumab.