We provide bioanalytical services to support preclinical and clinical studies. Our experienced scientists offer a full range of LC/MS/MS bioanalytical services from methods development and methods validation to GLP sample analysis. Our comprehensive bioanalytical services include:
LC/MS/MS and GC/MS method development and validation
Bioanalytical Chemistry Services is adept at identifying metabolites related to the parent compound of interest. We also have a 500 mHz NMR in house to assist in the identification of unknown metabolites.
Bioanalytical Chemistry Services has experience characterizing unknowns in drug products for pharmaceutical companies. Some examples of this experience are identifying contaminants in the manufacturing process and measuring API degradants too low to detect via standard HPLC.
Bioanalytical Chemistry Services has performed biological sample analysis in many different matrices (blood, urine, feces, aqueous humor, tissues, brain, plasma and serum) at sub-picogram levels.
Bioanalytical Chemistry Services employs a systematic approach for the development of simple molecules to complex chiral compounds. Upon development completion, the group will validate the method to GLP standards, producing a robust, reproducible method for clients in support of DMPK, Toxicology, or clinical trial studies.
Instrumentation
LC/MS/MS systems with ESI, APCI, APPI and nanospray ion sources
Sciex API 5000, 4000, 3000 and 4000 QTrap LC/MS/MS
Agilent 6410 LC/MS/MS
Waters Acquity TQD LC/MS/MS
Thermo Electron LTQ, LTQ ETD, and LCQ Deca LC/MSn
Hybrid and high-resolution MS
GC and GC/MS
UPLC and HPLC with PDA, UV, ELSD, RI, fluorescence and electrochemical detection
ICP-MS
CE with PDA
Additional Resources
Stable isotope and radiochemical synthesis
500 and 300 MHz magnetic resonance spectrometers
Quality assurance
DEA Registrations Schedule I–V
Preclinical toxicology and DMPK testing under FDA guidelines