Services
iC42 provides integrated solutions to systems biology. We are designed and uniquely qualified to carry out the bioanalytics for complex clinical trials involving drug quantification and molecular marker strategies.
- Molecular marker discovery and qualification
- Translational research
- Strategy development and the identification of molecular mechanisms
Projects range from the development and validation of assays and strategies with only a few study samples and clinical therapeutic drug monitoring to serving as the central laboratory for phase III clinical trials with more than 50 clinical centers and more than 10,000 samples – from bioanalysis to strategic research partnerships.
iC42 is mainly a cutting-edge mass spectrometry laboratory. Our staff is a unique and complementary blend of highly successful academic researchers and bioanalytical specialists with decades of industry experience.
- Highly Sensitive LC-MS/MS Bioanalytics
- Quantification of endogenous compounds and multiplexing technologies (metabolomics, proteomics)
- Molecular Marker Discovery, Qualification & Development
- Complex Assay Development & Validation
- GLP Compliant, CAP Accredited, CLIA Certified
- Quantification of Drugs & Metabolites
- Isolation of Drug Metabolites & Structural ID
- Clinical Therapeutic Drug Monitoring
- Complete PK/PD Package Managed Under One Roof
- Consulting & Strategic Research Partnership
Our team also promotes and enhances research in transplantation through the Colorado Center for Transplantation Care, Research and Education.
Learn more about personnel here to help you and your project.
Our team also promotes and enhances research in transplantation through the Colorado Center for Transplantation Care, Research and Education.
Specimen Collection
High-end Bioanalytic Services
iC42 Clinical Research & Development has developed into a global resource for “high-end’ bioanalytics that currently collaborates with more than 40 entities including academic groups, clinical networks, biotech and pharmaceutical companies all over the world.
- Quantitative Bioanalytics Methods
- Assay Development and Validation (following FDA, ICH/EMEA and CLSI guidances)
- LC-MS/MS Quantification of Endogenous Compounds
- Amino Acids High Energy Phosphates (LC-MS)
- Fatty Acid Profiling (GC-MS)
- Metabolic Profiling (“non-targeted metabolomics, GC-MS, LC-high resolution MS, 1H NMR)
- Targeted Metabolic Pathway Screening (“multiplexing” LC-MS/MS)
- High Energy Phosphates (31P NMR)
- Lipid Patterns (1H NMR)
- 13C-labeled tracers (13C NMR, “Fluxomics”)
- Isotope Ratio Mass Spectrometry and Measurement of Isotope Enrichment
- Non-Targeted Proteomics
- Targeted Quantification of Peptides and Proteins
- Drug Metabolism
- Purified and Certified Immunosuppressant Metabolites
Triple Quadrupole Mass Spectrometry
LC-MS/MS is used for analysis due to its high sensitivity and ability to test a high number of analytes in a short period of time (“high throughput testing”). The way various LC-MS/MS methods differ has been outlined extensively in literature.7 We use triple quadrupole mass spectrometry systems in the clinical laboratory. Quality assurance and quality control processes, which ensure the system is running as efficiently and effectively as possible, have also been applied into the daily, weekly, and monthly practices. The information outlined here is important not only for laboratory technicians who work with similar systems, but also the clinicians who require more information on how the results they receive were determined.
To be developed
- How to Work with iC42
- iC42 Test Directory
- Bioanalytical Services
- Clinical Therapeutic Monitoring
- Tox ID Screening
- Purified & Certified Drug Metabolites
- Custom Methodologies
- Complex Assay Development and Validation
- Biomarker Discovery, Qualification and Validation
- Metabolomics and Proteomics
- Pediatric Pharmacology
- Consulting