Bioanalytical Services >> Small Molecule

Protea’s Bioanalytical Service laboratory is a state-of-the-art GLP mass spectrometry facility, featuring high resolution exact mass MS/MS technology as well as the most advanced triple quadrupole systems and software. With over 25 years of combined GLP experience in small molecule analysis, we know what it takes to deliver your compound to market, from non-GLP drug discovery through Phase 3 support in a GLP compliant laboratory. All GLP work is performed in accordance with US 21CFR Part 58, US 21 CFR Part 11, US FDA Guidance for Industry (Bioanalytical Method Validation), and current industry and regulatory practices.

Drug Discovery Services

• Combinatorial library hit identification
• Hit-to-lead assay development
• Lead optimization
• LC-MS/MS assay development and screening
• Support for secondary lead compounds
• Rapid turn-around for non-GLP, PK screening through candidate selection, and optimization
• Metabolite ID and profiling

Sample Analysis Diversity
Protea is experienced in analyzing blood products (plasma, red/white blood cells, peripheral blood mononuclear cells), tissues (liver, kidney, spleen, lung, heart, brain, reproductive organs, eyes) and body fluids (lymph, synovial fluid, sweat, tears, bile, saliva)

• Capacity for assaying up to 6000 plasma samples per week
• Draft reports available within 5 days of last sample analyzed

Method Development and Validation Services
Protea specializes in developing and validating reproducible methods for the analysis of a wide array of compounds:

• Novel method development
• Method transfers and verifications
• Cross-matrix & cross-species validations
• Full GLP method validation
• Draft validation report provided within 10 days of start of validation

Validated Assays

• Phenylpropanolamine
• Buprenorphine/Norbuprenorphine
• Ropivacaine
• Metoprolol
• Methadone
• Tramadol/M1/M2/M5

Parameters assessed in a typical bioanalytical validation:

• Specificity/Selectivity
• Carryover
• Matrix Effect/Recovery/Process Efficiency/Extraction Yield
• LLOQ Accuracy and Precision
• Intra-Day Accuracy and Precision
• Inter-Day Accuracy and Precision
• Dilution Integrity
• Relative Post Extract Stability
• Solution Stability (refrigerator, freezer and bench top)
• Sample Stability
• Bench Top stability
• Freeze-Thaw stability
• Long-Term Storage stability
• Whole blood stability and concomitant-medications

Depending on your needs, we can also test:

• Storage container differences (ex. glass vs. polypropylene)
• Anticoagulant differences (ex. EDTA vs. heparin)
• Incubation variances
• Consumable differences (ex. vendor vs. vendor)