Back in January we wrote about fit-for-purpose bioanalytical assay support and announced a new small molecule LC-MS/MS screening level assay service at AITB. Well, we’ve put this process through its paces and have shown our ability to consistently get variability down below 35% and in many cases down below 20%. For a go-no/go decision point in the program, this low variability in the data gives confidence in the decisions being made.
As compared to all-in-one CROs that are not experts in bioanalysis, the bioanalytical focused expertise of AIT Bioscience allows us to leverage our extensive chemistry and assay development expertise even in early non-GLP assays. The Speed plus Science approach is proving a vital tool for researchers in early phase development who are trying to balance budgets with assay rigor, intended use of the data, and rapid decision making ability for a program.
We highlighted two case studies in our recently developed Small Molecule Screening Level Assay capabilities sheet on opposite sides of the small molecule chemistry spectrum. Metformin, a low molecular weight highly polar compound vs. Everolimus, a large lipophilic/hydrophobic macrocycle.
Performance: %CV (Co-efficient of variance) for Everolimus was less than 5% at both the Low QC and High QC levels. For Metformin, %CV was at 10% for Low QC and 31% at High QC levels. FDA acceptance criteria for a validated bioanalytical method is 15% CV (20% at LLOQ).
Contact us today to see how using an expert contract bioanalytical lab can bring value to your PK, TK, IND Tox, or clinical programs.