Bioanalytical Services

Southern Research provides bioanalytical services for the comprehensive evaluation of drug and biologics candidates supporting both GLP and non-GLP studies. Bioanalytical services are conducted in more than 10,000 square feet of custom-designed, dedicated pharmacy and laboratory space. These facilities house state-of-the-art instrumentation and automation including LC/MS, LC/MS/MS, GC, GC/MS, and qPCR analytical platforms. Data can be handled through a validated LIMS system. We also have access to other analytical techniques including ICP, ICP-MS, XRD, SEM, and NMR.


Pharmacokinetics

• Single- and multiple-dose evaluations
• Absolute and relative bioavailability
• Dose proportionality and linearity of absorption and disposition kinetics
• Pharmacokinetic species-to-species extrapolations


Absorption, Distribution,
Metabolism, and Elimination

• Protein-binding determinations
• Mass balance
• Rates and routes of elimination
• Single- and multiple-dose tissue distribution evaluations including isolation and identification of metabolites in plasma, serum, urine, feces, bile, and special tissues CSF, ocular)
• Pathway definition and species- to-species comparisons


Pharmacodynamics

Including correlation of drug levels to:

• Target- or organ-specific enzyme activity
• CBC alterations
• Tumor growth
• Cell permeability


Bioanalytical Chemistry

• Development and validation of methods for optimal sensitivity, specificity, accuracy, precision and limit of quantification
• Measurement of parent compound and metabolites from biological tissues and fluids
• Sciex mass spectrometers


qPCR Laboratory

• Custom designed, developed, and validated TaqMan® and Molecular Beacons™ assay
• Isolation and purification of DNA and RNA from biological matrices
• Quantification of DNA and RNA
• Detection of DNA and RNA for biodistribution and gene expression analysis
• Vaccine efficacy analysis and viral/bacterial load screening


In Vitro Metabolism Laboratory

• Determination of metabolic profiles and relative rates of biotransformation using hepatocytes, microsomes, and S9-fractions
• Qualitative determinations of Phase I and Phase II drug metabolizing enzymes

All services available with GLP compliance



How To Work With Us

As a CRO service provider, Southern Research’s Drug Development division has a straightforward business model. Contact our business development representative by clicking here. A confidentiality disclosure agreement will be initiated (your agreement or ours) to facilitate detailed discussions around your specific needs. One of our subject matter experts will be brought into the discussion to ensure we have a comprehensive understanding of your project. A proposal will then be prepared, outlining the tasks to be accomplished, along with a budget and timeline. Upon acceptance of the proposal, a contract will be provided to establish the legal framework for the project.