Drug Development ::

Our focus of bio-analytical drug development is to provide an accurate measure of the active drug and/or its metabolite(s) in samples collected from cell culture media, plasma, serum, urine, or other biological matrices from either animals or humans.

Our experienced team of PhD-trained scientists has developed and validated sensitive bio-analytical methods using liquid chromatography tandem mass spectrometry (LC-MS/MS) for determining the concentrations of small molecules, drugs and their metabolites in a wide variety of biological matrices. We can also support your research in screening compoud portfolios, preclinical to early clinical (PK/PD) studies and rapid clinical sample analyses.

The scientific data we have generated has helped guide the development of novel small molecules toward approved pharmaceutical use. Pharmaceutical testing, bio-analytical method validation and data analysis are conducted under GLP regulations according to FDA guidelines (21 CFR Part 58), unless requested otherwise.

Please contact Custom Biologics™ for a non-commital consultation on how we may assist with your drug development needs.  We would be delighted to speak with you.