Regulated bioanalysis stands on the precipice of global harmonization, while emerging therapeutic technologies present new challenges.
By Jennifer A. Vance, Ph.D., Associate Director of Scientific Services; Shelby Anderson, Ph.D., Chief Scientific Officer; Ashley Brant, M.S., Associate Director of Scientific Services; Mark Cameron, M.S., VP: Ligand Binding Assays; Swarna Ramaswamy, Ph.D., Senior Scientist: Immunogenicity; and DeAnna Travis, B.S., QA Analyst II, AIT Bioscience
The past 30 years have been a time of accelerated growth and development in bioanalysis. In particular, the last 10 years have seen a flurry of regulatory guidance around the globe culminating in the release of the draft ICH M10 Harmonized Guideline on Bioanalytical Method Validation (BMV) in February 2019 (Figure 1).