FDA Defense – Cell Proliferation/ Toxicity/ HUVEC Assays
Posted on Aug 11, 2017
Does the FDA require you to have a bioassay for potency lot releasing testing?
Do your chemists or physiologists or clinicians or marketing department want quantitative data on how your drug works?
Multiple cell lines have been assayed at Marin Biologic Laboratories in proliferation/toxicology assays. Two main assays are used “Alamar blue” and “Cell Titer Glo”. Both assays are designed to measure quantitatively the proliferation of various human and animal cell lines. Both assays are simple to perform since cell washing, removal of medium or multiple pipetting steps are not required.
AlamarBlue detects the reductive environment inside healthy cells.
CellTiter-Glo® (Promega) measures intracellular ATP, a sign of metabolically active cells.
We developed this method to measure factor dependent proliferation and inhibition of slow growing human umbilical vein endothelial cells (HUVEC).
Inhibition of HUVEC growth by an antibody to VEGF, Vascular Endothelial Growth Factor.
We work with state of the art equipment, but no matter how good or advanced the equipment is, it’s only as good as the science and scientists running the results. Your results may take a few additional days, but you will see better results and get the information you can count on, and in this case, take to the FDA.