Bioanalytical Services
LC-MS/MS bioanalysis for clinical development
Crux Biolabs provides LC-MS/MS bioanalysis to support pharmacokinetic and pharmacodynamic studies throughout clinical development. Our scientists develop, qualify and validate fit-for-purpose methods for the quantitative measurement of small molecules and other applicable analytes in biological matrices.
Combining UHPLC separation with tandem mass spectrometry, we generate sensitive, selective and reliable data to support informed development decisions and clinical-study delivery.
Flexible LC-MS/MS bioanalysis
Crux Biolabs provides sensitive, selective quantitative LC-MS/MS analysis for clinical research programs. Our services include pharmacokinetic studies, pharmacodynamic assessments, metabolite monitoring and formulation-related analytical requirements, depending on the study design and analyte.
We work with sponsors to develop fit-for-purpose analytical strategies based on the therapeutic modality, expected concentration range, sample matrix, sample volume and required study endpoints. From method feasibility through to validated sample analysis and reporting, our team provides practical scientific support throughout the project lifecycle.
Designed around your study
| Study consideration | How Crux approaches it |
|---|---|
| Analyte and modality | Select an LC-MS/MS strategy based on the analyte’s chemical properties, therapeutic modality and expected concentration range |
| Biological matrix | Develop methods with the relevant matrix, sample volume, collection conditions and potential interferences in mind |
| Assay performance | Establish fit-for-purpose sensitivity, selectivity, precision, accuracy, stability and reportable range based on the method’s intended use |
| Method lifecycle | Support method feasibility, development, qualification and validation, transfer and clinical sample analysis as required |
| Study delivery | Align sample workflows, data review and reporting with the protocol, project plan and study timeline |
Applications in clinical research
LC-MS/MS is well suited to quantitative analysis where sensitive and selective measurement is required. Crux Biolabs can support:
Small-molecule PK
Quantification of drug candidates in relevant biological matrices
Metabolite monitoring
Measurement of relevant metabolites where required by the study
Pharmacodynamic and biomarker analysis
Quantification of applicable small-molecule endpoints
Formulation-related analytical support
Supporting analytical questions related to investigational products, where applicable
Method transfer and optimisation
Adapting established methods for the study, matrix and required performance characteristics
UHPLC and tandem mass spectrometry
Our Agilent LC-MS/MS capability combines UHPLC separation with tandem mass-spectrometric detection. UHPLC supports efficient separation of complex biological extracts, while tandem mass spectrometry supports selective identification and quantitative measurement of target analytes.
This platform supports robust method development and analysis where concentration range, matrix complexity, specificity and throughput are critical study considerations.
Quality and compliance
Crux Biolabs’ LC-MS/MS services are delivered within a quality framework aligned with applicable regulatory expectations for clinical bioanalysis. We apply fit-for-purpose method development, qualification and validation approaches based on the intended use of each assay and relevant bioanalytical guidance, including ICH M10 where applicable.
Crux Biolabs operates an ISO/IEC 17025-accredited, GCLP-compliant quality management system. Controlled processes, documented procedures and data-review practices support reliable, traceable and scientifically defensible results for clinical research.
Accelerate your program with established LC-MS/MS methods
Crux Biolabs offers selected established LC-MS/MS methods that can provide an efficient starting point when the analyte, biological matrix, concentration range and study objectives align with an available method.
| Method | Platform | Sample matrix | Reportable range |
|---|---|---|---|
| Cannabidiol (CBD) | LC-MS/MS | Plasma | 1-1,000 ng/mL |
If an established method is not suitable for your required analyte, matrix or intended use, our scientists can develop and validate a fit-for-purpose LC-MS/MS method for your program.
