ADME/PK

Drug Disposition

Southern Research is a preclinical drug discovery and development contract research organization focusing on cancer, neurological/CNS disorders and infectious diseases, including emerging pathogens. With 6 FDA-approved drugs and another 6 compounds in late stage preclinical development or clinical trials, Southern Research continues to demonstrate value to its partners in the search for tomorrow’s breakthrough discoveries.

Since its founding in 1941, Southern Research has evaluated approximately 80% of all FDA-approved cancer drugs and tested 75% of the anti-viral drugs. Southern Research offers joint discovery programs with out-licensing of clinical candidates and a comprehensive array of drug development services including: medicinal and combinatorial chemistry; high-throughput screening; molecular and cellular biology; lead optimization; ADME/PK; toxicology; drug delivery; and, clinical pharmacokinetics.

Services include: formulation preparation and optimization - homogeneity, concentration, and solubility; bioanalytical method development and validation; feasibility studies; plasma and tissue drug level determination; in vitro metabolism; matrix stability; protein binding; and RT/Q-PCR.

Pharmacy

• Receipt, storage, tracking and disposition of test articles and study related compounds
• Preparation of dose formulations for in vivo studies in a wide variety of matrices, including food-grade oils, aqueous suspensions and solid blends
• Feed and water admixture formulation
• Formulation dispensing for administration (e.g., sterile filtration, dosing bottles, syringes, capsules, iv bags)

Bioanalytical Chemistry

• Fully GLP-compliant bioanalytical chemistry services
• Dose formulation assays (concentration, homogeneity, stability)
• 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

Our state of the art instrumentation includes:

• HPLC UV/VIS, fluorescence detection
• LC/MS
• LC/MS/MS
• LC/FTIR
• GC, GC/MS electron-impact and chemical ionization sources
• Ion chromatograph and Scintillation counter

PCR Laboratory

• Fully GLP-compliant Q-PCR services
• TaqMan® and Molecular Beacon® probes
• Extensive experience in primer and probe design
• PCR optimization, target sequence validation, and data analysis and interpretation
• Isolation and purification of DNA and RNA from biological matrices
• Quantitation of DNA and RNA using PicoGreen/RiboGreen
• Detection of DNA and RNA sequences for biodistribution and target gene expression
• Analysis of DNA and RNA copy number

In Vitro Metabolism Laboratory

• Determination of metabolic profiles and relative rates of biotransformation using microsomes and S9-fractions
• Qualitative determinations of Phase I and Phase II drug metabolism, including CYP isoforms for induction and transformation studies

Microarray Laboratory

• GLP-compliant gene expression profiling and genotyping services through Genome Explorations
• Affymetrix GeneChip platform permits robust and precise genome-wide expression analysis in a large number of eukaryotic and prokaryotic organisms or genotyping of 10K, 100K or 500K SNPs in human samples
• Comprehensive service includes DNA or RNA QC testing, DNA or RNA processing, labeling, hybridization and scanning, and data normalization
• Service includes comparative expression analysis to identify regulated genes, LOH and chromosome copy number analysis
• Extra services include DNA and RNA isolation, globin reduction (for whole blood samples), small-sample amplification, and advanced data analysis