Bioanalytical Sciences

The Southern Research Bioanalytical Sciences Department provides bioanalytical research services for the comprehensive evaluation of drug candidates, supporting preclinical GLP and non-GLP studies and clinical sample analyses. Our services include:

• Formulation preparation and optimization
• Homogeneity testing
• Solubility and stability testing
• Solubility testing
• Bioanalytical method development and validation
• Feasibility studies
• Plasma and tissue drug level determinations (PK/TK, bioavailability and biodistribution)
• In vitro metabolism studies
• Matrix stability studies
• Protein binding studies
• Proteomics
• Quantitative PCR

The Pharmacy Laboratory is equipped to prepare, store and distribute dosing formulations for in vivo, stability and homogeneity studies. Our technical staff is highly experienced in preparing formulations in a wide variety of matrices including food-grade oils, feeds, aqueous suspensions, solvents, and drinking water. Our laboratories are outfitted with an assortment of equipment used for mixing formulations including simple stir-plates, sonifiers, and small blenders as well as three 16-quart V-blenders with intensifier bars, several mixers capable of homogenizing, emulsifying, and dispersing materials, and two large aerating mixers. We have the capability to store formulations and samples at ambient temperature to -80 °C. Our technical staff is experienced in dispensing formulations in dosing bottles, syringes, capsules, and IV bags.

The Bioanalytical Chemistry Laboratory offers a comprehensive array of preclinical and clinical services designed to exceed our clients’ expectations. The laboratory core services include dose formulation assays, drug and metabolite level determinations in biological fluids and tissues through all stages of the drug discovery/development process. Additional services include method development/validation, method transfer, cross and partial validations of client-supplied methods. Our labs are equipped with state-of-the-art instrumentation including:

• BSL-2 rated sample preparation labs
• LC/MS/MS
• LC/MS
• HPLC with UV-VIS, fluorescence
• GC with FID and ECD detectors
• GC/MS with PCI, NCI and EI ionization sources
• Scintillation Counting (radiolabled compounds)

The Proteomics Laboratory offers an integrated, industry-leading platform of research services to identify drug targets, characterize proteins, determine differential protein expression, and identify protein biomarkers. The proteomic technologies used in this laboratory include:

• Sample preparation (protein assays, sample clean-up)
• 2-D electrophoresis (broad and narrow range IPG strips, SDS-PAGE)
• Image analysis (Coomassie or Sypro® Ruby staining, protein expression profiling)
• Protein identification by mass spectrometry (MALDI-TOF, Q-TOF)

The In Vitro Metabolism Laboratory evaluates compounds using microsomes and S9-fractions or hepatocytes from different species to determine metabolic profiles and relative rates of biotransformations. Our expertise allows us to modify experimental conditions through the inclusion of various co-factors to make qualitative determinations of phases I and II drug metabolism.

The PCR Laboratory offers a full range of quantitative PCR services including TaqMan^® and Molecular Beacon^® probes. We have extensive experience in primer and probe design, PCR optimization, target sequence validation, and data analysis and interpretation. Our capabilities include:

• Isolating and purifying DNA and RNA from biological matrices
• Quantitating DNA and RNA using PicoGreen/RiboGreen
• Detecting DNA and RNA sequences for biodistribution and target gene expressions
• Analyzing DNA and RNA copy number by the Limiting Dilution Assay