Bioanalytical Laboratories

Bioanalytical Laboratories

We are focused on providing accurate, high-quality results in a timely, secure, and cost-effective manner.

Leveraging state-of-the-art instrumentation, techniques, and facilities, our team of experts has experience in a broad range of small and large molecule bioanalytical and biomarker support. Working in a good laboratory practice (GLP) compliant setting, the Medpace Bioanalytical Laboratories provide method development, transfer, validation, and analysis of preclinical and clinical biological samples. We have extensive expertise in developing sensitive methods for LC-MS/MS – qualifying multiple-analytes, metabolites, prodrugs, and light- and temperature-sensitive compounds. Our discovery team regularly supports fast PK, bioavailability, and early toxicology studies.

Expertise

Advanced, mass spectrometry technologies for bioanalytical and biomarker analysis qPCR for nucleic acid drug pharmacokinetics (PK) or pharmacodynamics (PD) All bioanalytical aspects for small and large molecules conducted according to GLP, OECD, and ICH guidelines
Ligand-binding assays for pharmacokinetics (PK) and immunogenicity assays  Rapid transition of methods between species and matrices

Experience

Dose escalating studies, with analysis and reporting capabilities for thousands of samples within short timeframes Clinical PK/bioavailability studies Drug-drug interaction studies
Method development, feasibility, and validation Bioequivalency studies Pre-clinical and clinical sample analysis
Nonclinical toxicokinetic (TK) studies Bioavailability studies Clinical study-compliance samples
Pharmacokinetic (PK) screening Drug discovery

Labeling, Shipping, and Storing Biological Samples Services

Refrigerated storage (4ºC) Emergency back-up electrical and heating services Onsite archive facility
Low-temperature storage (-20ºC, -70ºC, and -80ºC) Video security Barcoding system

Instrumentation and Software

Sciex 6500 High-Sensitivity Q Trap LC-MS/MS system PerkinElmer ICP-MS NexION 300X for Metal compounds Validated Watson LIMS System vs7.3
Sciex 5600 High-Resolution Q-TOF Lc-MS/MS system ELISA instruments with Absorbance, Fluorescence, Luminescence Automated sample preparation and TomTech Quadra SPE 4
API-5500 Sciex Q trap LC-MS / MS Systems (with SelexION-Ion Mobility) MSD Sector Imager 2400 (Multiplex) Validated Watson LIMS System v7.3
API-4000 Sciex LC-MS / MS Systems Eppendorf qPCR (Realplex) Fully Validated (IQ/OQ/PQ, Software) Systems
UFLC Shimadzu LFLC/HPLC LC-30XR Systems (19,000 PSI) GC-MS Complete services for labeling, shipping, and storing biological samples
HPLC Shimadzu UFLC / LC-20 Systems Flow Cytometer and Microscope