Small Molecule Bioanalysis

MBR offers expertise in assay design, method development, and GLP validation for small molecule drug candidates, including peptides and metabolites, analyzed from a variety of dose formulations, and biological matrices, including tissues.

Our highly trained staff has extensive experience and technology to generate results for making decisions at the late discovery and development phases. Additionally, we have expert capabilities to produce regulatory-compliant results from large numbers of samples from clinical or preclinical projects.

MBR offers expertise in structure elucidation of metabolites and impurities, using state-of-the-art LC-MS/MS equipment. With our access to the Analytical Services Laboratory at Northwestern University, we can offer a full range of sophisticated instrumentation for structure analysis. Our experience includes the reporting of structure identification data and impurity qualification results to regulatory agencies.

Our capabilities include:

LC-MS/MS (qualitative and quantitative)
HPLC with diode array UV/VIS, fluorescence, radiochemical detection
Automated sample processing and analysis
Validated Watson-LIMS
GLP and non-GLP Assays:
- Dose formulation analysis
- Metabolic stability and profiling
- Plasma protein binding
- Method validation (bioanalytical and analytical)
- PK/TK and PD/TD analysis