Bioanalysis

Southern Research offers a comprehensive array of preclinical and clinical bioanalytical services designed to meet clients' specific research needs. Our highly trained scientists have expertise in developing and validating quantitative methods for challenging and novel drugs/metabolites using mass spectrometry and UV detection. Our bioanalysis laboratory is also capable of carrying out qualitative analyses to support metabolism and metabolite identification studies.

Capabilities

Our expertise is focused on developing extraction protocols for drugs and metabolites that require innovative methods in a wide array of biological matrices. Example matrices can include various biological fluids such as plasma, urine, and serum, as well as tissues such as prostate, liver, and brain. Typically, a project begins with method development (short cycle time and robust methods) and is quickly followed by validation. We have significant instrument capacity to support sample analysis from all types of preclinical and clinical studies. If required, the laboratory has significant experience in method transfer or cross and partial validations of client-supported methods.

The goal of our bioanalysis group is to provide reliable concentrations of the drugs and metabolites in biological matrices through all stages of the drug discovery/development process for pharmacokinetic and toxicokinetic analyses. All Southern Research protocols are performed in compliance with the U.S. Food and Drug Administration's (FDA) Good Laboratory Practice (21 CFR Part 58 and 21 CFR Part 11). If required, we can also support non-GLP work, including in the drug discovery setting. In addition to LC-based methods, we also have the capability to develop and validate GC and GC/MS methods for volatile analytes not amenable to atmospheric pressure ionization. Our capabilities can be summarized as follows:

• Extraction methodology from a biological matrix
• Protein precipitation
• Liquid/liquid extraction
• Solid phase extraction
• Method development and validation
• LC/MS/MS
• HPLC/UV
• GC-MS

Instrumentation

The instrumentation and software in the Bioanalytical Laboratory is validated to be GLP-compliant. State-of-the-art instrumentation utilized in our Laboratory includes:

• BSL-2 rated sample preparation labs
• LC/MS/MS (1 API 3000, 3 API 3200, 1 API 4000Q-TRAP)
• HPLC with UV detection (5)
• GC with FID and ECD detectors
• GC/MS with PCI, NCI, and EI ionization sources
• Scintillation counting (radiolabeled compounds)

API 3000/3200 Triple Quadrupole (Applied BioSystems)

API 3000/3200 are equipped with a turbospray ion source for electrospray ionization. The triple quadrupole system allows monitoring in the product ion scanning, parent ion scanning, neutral loss scanning, or most commonly in multiple reaction monitoring (MRM). The MRM mode of operation enables quantitation of analytes at low levels due to the specific nature of the mass transition. Product ion scans can be very useful for acquiring structural information on a single or series of analytes.

API 4000-QTRAP (Applied BioSystems)

The API 4000-QTRAP is a linear ion trap. Similar to the triple quadrupole, it has the added advantage of having the third quadrupole replaced by a trapping quadrupole that enables the additional capability of MS3 in the trap. This system comes with electrospray and atmospheric pressure chemical ionization sources.

Perkin Elmer HPLC with UV Detection

The Perkin Elmer HPLCs have dual wavelength detectors with one HPLC equipped with a diode array detector.

HP5973 GC-MS

The HP 5973 GC-MS is equipped with a single quadrupole for detection. It is a robust instrument for analysis of small molecules amenable to gas chromatography. Additionally, it is equipped with electron impact ionization source and has the capability for positive and negative ion chemical ionization.

Agilent 6890N GC-FID/ECD

The Agilent 6890N is equipped with a dual flame ionization/electron capture detector (FIC/ECD). The FID is the workhorse detector of gas chromatography, as it is a universal detector for a majority of volatile small molecules. The ECD is a good complement to the FID, as it enables detection of chlorinated compounds as well as compounds that have a high electronegativity.