Regulated LC-MS/MS Bioanalysis
With over 25 years’ experience in regulatory bioanalysis using LC-MS/MS, we specialise in developing and validating reliable methods for the analysis of a wide range of analytes, including small molecules, peptides, proteins, metabolites, and biomarkers.
Experts in Complex Bioanalytical Challenges
Our team has substantial experience in addressing complex bioanalytical requirements, 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
- Optimised processes enable timely study initiation and completion, from sample receipt through 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 timely delivery of safety-relevant 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 validated assays are designed to perform consistently across batches, supporting data integrity and reproducibility.
Instrumentation: We utilise 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)