In analytical chemistry, Synelvia proposes the following services:
- Analytical development on request
- Validation, transfer of analytical methods to ICH guidelines for active ingredients (herbal drugs) and galenic forms (solids, semi-solids and liquids)
- Analytical support for galenic development
- Stability studies (stability indicating methods)
- Suppliers selection/accreditation for raw materials
- Establishment of Monographs for NCEs
The technologies of interest are principally chromatographic methods:
- LC/UV/Fluo/CAD (analytical autosampler with fraction collector)
- LC/MS and LC/MSMS with ESI/APCI
- GC/MS (EI, CI with CTC injector an SHS, DHS and TDU)
Synelvia has the possibility to perform in-house analytical development and validation of validated surrogate biomarkers or other biomarkers.
With our expertise in analytical development and validation, we can help you in the implementation of new, robust and easy to use analytical methods of biomarkers in various biological matrices.
Validation of the analytical methods is performed in adequation with the objective of the study: validation of key parameters for POC to full validation for clinical studies.
Depending on the intended use of the biomarker, we can determine the level of validation required (full GLP validation or specific requirements).
In parallel to biomarkers analysis (pharmacodynamics studies), active ingredients or metabolites can be analyzed in biological matrices for early pharmacokinetics (PK), or PK/PD relations evaluation.
Analytical services are performed in a strong quality environment in a wide range of matrices:
- Plasma / serum / Bile / Urine
- Feces & stools
- Soft tissues (liver, brain, muscles,…)
- Cells / supernatant
- Reconstructed human epidermis / explants / skin biopsies
- Dander (hair, nails…)
- Sebum / surface skin lipids
- Specific non invasive samplings
The technologies of interest are principally chromatographic methods (LC/UV, LC/Fluo., LC/MS, LC/MSMS, LC/CAD, GC/MS) and immunoassays (ELISA/EIA, HTRF®, Biacore®).
These services permit the evaluation of efficacy of drug candidates, PD and efficacy in pre-clinical development or clinical studies, PK/PD relationships and/or early PK / tissue distribution.
Find hereafter some examples of analytical services applications:
- Lipidomics / lipids exploration
- Oxidative stress markers assays
- Inflammatory markers analysis
- Volatil organic compounds (VOCs) exploration
For other assays, please inquire.