Bioanalytical Chemistry Services
WIL Research Laboratories, LLC has performed a wide range of bioanalytical assays in support of clinical, PK/TK, toxicity, metabolism, and other regulatory studies for pharmaceutical, biotechnology, agrochemical and industrial clients.
Significant expertise in sample preparation procedures, liquid and gas chromatography using mass spectrometry or a wide variety of other detection systems, and rapid method development and validation is provided by experienced doctoral applications chemists supported by a team of highly qualified analytical chemists. All standard operating procedures were established in accordance with FDA guidance documents. The result is precise, accurate, and high-quality data, all developed in accordance with Good Laboratory Practices (GLP).
Whether transferring a client's analytical method or developing a novel method, we use a solid, scientific approach to identify solutions and meet timelines.
General Capabilities
- Method Development: WIL’s expert bioanalytical chemists have developed hundreds of methods specific to our study sponsor’s needs.
- Method Validation: Our method validations ensure long-term success for the method and cover all essential factors—system suitability, calibration reproducibility, accuracy, precision, stability, specificity/selectivity, limits of quantitation, recovery, carry-over and ruggedness.
- Routine analysis: Acceptance of results is defined by pre-established criteria based on QC samples analyzed concurrently with study samples.
- Bioanalysis for clinical and non-clinical samples.
Instrumentation
All instruments are fully automated and software systems have been validated in accordance with a rigorous facility validation program that meets GLP and Part 11 requirements.
- Mass Spectrometers
- MDS Sciex API 5000 with Spark Holland Symbiosis Pharma XLC
- MDS Sciex API 4000 with Spark Holland Symbiosis Pharma XLC
- MDS Sciex API 4000 with Agilent 1200 HPLC (also with PDA detector)
- MDS Sciex API 4000 with Agilent 1200 HPLC (also with PDA detector)
- Micromass Quattro Ultima with Agilent 1100 HPLC (also with DAD)
- Micromass Quattro Micro with Waters 2695 HPLC
- Micromass Quattro Micro with Waters 2695 HPLC
- Varian Saturn Ion trap GC-MS (also with FID)
- Agilent 6890 GC with 5975 MSD
- Sample Preparation Equipment
- Apricot Design and Argonaut 96-well plate evaporators
- Cerex SPE processors
- Savant SpeedVac
- Other instrumentation available in our Analytical Chemistry Laboratory and Metabolism Laboratory
Facilities
Our facility has undergone an extensive validation to ensure proper operation and compliance with GLP requirements.
- State-of-the-Art Laboratory Complex – over 28,000 sq. ft.
- 100% fresh air to reduce concerns with airborne contamination
- Large sample preparation lab – over 2,350 sq. ft.
- Automated sample preparation laboratory – over 380 sq. ft.
- Custom-designed instrument laboratory – over 3650 sq. ft. for chromatography and mass spectrometry
- Separate room for storing and weighing test articles and standards
- Auxiliary instrument laboratory
- Isolated rooms for special analyses
- Estimated annual facility capacity in excess of 250,000 samples
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