Regulated LC-MS/MS Bioanalysis
Experts in Complex Bioanalytical Challenges
With over 25 years of experience in regulatory bioanalysis using LC-MS/MS, we specialize in developing and validating reliable and robust methods for analyzing a wide variety of analytes, including small molecules, peptides, proteins, metabolites, and biomarkers. Our expertise extends to solving complex bioanalytical challenges such as unusual matrices, unstable analytes, pro-drugs, multiple analytes, sub pg/mL LLOQ, multi-dimensional methods, hybrid assays, and patient-centric micro sampling.
Key Services:
- Small molecule, peptides, proteins, and biomarkers bioanalysis
- Method development and method transfer
- Assay qualification for exploratory endpoints
- Full validation to current international regulatory standards
- GLP-compliant preclinical and clinical GCP sample analysis
- Bioanalytical regulatory and scientific guidance and expertise
- Pre-determined strategies for small molecule regulated bioanalysis
- High potency and high sensitivity LC-MS/MS analysis
- ADA (Anti-Drug Antibody) analysis
- Rapid study start-up and completion with efficient processes from sample receipt to final reporting
Validated LC-MS/MS methods for sensitive, reliable analysis of small molecules, peptides, and biomarkers.
Applications: Our services support first-in-human studies with fast turnaround of safety-critical data (including weekend provision and twice-weekly dosing support), patient-centric microsampling to enable patient-focused clinical trials, and complex bioanalysis challenges including hybrid methods for proteins and biomarkers, unstable analytes, pro-drugs, multi-dimensional methods, unusual matrices, and sub pg/mL LLOQs. We also offer biomarker assays based on context of use and support COVID studies. Our robust assays run seamlessly from batch to batch with minimal variability, providing tighter data.
Instrumentation: We utilize a range of advanced technologies, including:
- LC-MS/MS systems (Waters™ Xevo TQ Absolute, TQ-XS, TQ-S, SCIEX™ TQ 6500+, API5000, and API 4000)
- UPLC Waters™ Acquity FTN and FLI systems
- Symbiosis Pharma systems (on-line SPE)