Our Bioanalytical Group at Absorption Systems provides quantitative measurements on a range of active drugs (small molecules to peptides) or metabolite(s) in biological matrices such as plasma, serum, urine, feces, bile and tissues.

 The group's capabilities include:

• Performance of both GLP-compliant and non-GLP method development for analytical and sample preparation
• Performance of bioanalytical work with the rigor required to satisfy regulatory agencies such as the United States FDA
• Support of ADME screening, preclinical pharmacokinetic (PK) and toxicokinetic (TK) studies
• Performance of GLP bioanalysis of plasma samples from human clinical trials
• Handling projects ranging in size from a few to several thousand samples
• Analysis of thousands of samples a week using LC/MS/MS
• Bioanalytical method development and transfer
• Determination of test article stability
• Putative metabolite identification, screening, and collection of samples generated from both in vitro and in vivo studies

Instrumentation includes

• Applied Biosystems 4000 Q TRAP LC/MS/MS System
• PE Sciex API 4000’s, and API 3000’s
• Leap CTC Analytics Autosamplers
• Tomtec Quadra 96 robotic sample prep workstation

The LC/MS/MS data is generated using Analyst Version 1.4.1® compliant with 21 CFR, Part 11, and all customer reports are archived in a validated NuGenesis 6.01 database compliant to 21 CFR, Part 11.

All bioanalytical projects, from the simplest sample preparation to the most complex method validation, are approached with a focus on excellence, efficiency, and speed.

Please contact Absorption Systems  to learn how the Bioanalytical group can assist you in your next project.