[PEGS 2018] Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, & Ranibizumab

[PEGS 2018] Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, & Ranibizumab
Version:
20801

File Name/Number:
PEGS 2018

Year:
2018

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.