Nonclinical and Clinical Assays
Through our unique position as a leading provider of nonclinical and clinical analytics, our scientists are experts at assay life cycle management. This ensures that assays and testing paradigms applicable in nonclinical research are appropriately transitioned to the clinical phase, eliminating the need for costly and often difficult method transfer between laboratories.
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
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From small to large molecules, and at any phase in development, Saint-Nazaire has the tools required to quantify and characterize drugs and metabolites in various animal and human biological matrices (e.g., plasma, whole blood, urine, excreta, bile, tears, CSF, tissues, etc.).
Large Molecules
For large molecules, bioanalysis assays are run by liquid chromatography-mass spectrometry (LC-MS/MS).
By LC-MS/MS
The use of LC-MS/MS promotes the fast development of robust and specific assays for the quantification of multiple large molecules such as peptides, proteins, monoclonal antibodies, ADC (for the antibody and the conjugate part), or oligonucleotides. The characterization of modifications, metabolites, peptide mapping is also possible for all biologics.
Our experienced team can prepare fit-for-purpose sample preparations including enzymatic digestion (e.g., trypsin) with or without immuno/affinity capture, as well as measurement in intact mode using LC-MS and HR-MS (High-resolution mass spectrometry).
Development and Validation of a Method by LC-MS/MS for Non-Clinical and Clinical Studies
Developing generic methods for the quantification of therapeutic antibodies by mass spectrometry in multiple matrices, with one therapeutic antibody, Pembrolizumab, an anti-PD1 compound.
Download the poster
Small Molecules
For your small molecule development, it is important to run the most sensitive and robust assays available. The following equipment allows us to reach those key points for analysis of active compounds and metabolites in various biological matrices:
• Automated and fit-for-purpose sample preparation (Protein crash, LLE, SPE…)
• Last generation LC-MS/MS (ABSciex API6500)
• High resolution mass spectrometry (HR-MS, Q-ToF)
• GC/MS
With more than 50 validations conducted and a capacity of more than 100,000 samples analyzed annually, Saint-Nazaire is ready to take on your bioanalytical testing.
With multiple platforms available to provide support to toxicology findings or PD readouts from preclinical to clinical samples (e.g., ELISA, ECLA®, chromatography (liquid/mass), RIA, LC-MS, HR-MS), Saint-Nazaire will be able to identify your soluble biomarkers (in single and MultiPlex) for cytokines/chemokines, hormones, immunoglobulins, complement factors, injury markers (bone, cardiac, kidney, etc.), and more.
Find the Right Biomarker for Your Project
Our biomarker database can help you ease the burden of finding the right one(s) for your project. Browse this interactive tool by therapeutic area, toxicological indication, and species, or enter in your search criteria to find what you need.
Explore Our Database
Frequently Asked Questions (FAQs) About St. Nazaire Facility on Bioanalysis and Biomarkers
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Is Charles River Saint-Nazaire certified?
For nonclinical safety studies, Charles River Saint-Nazaire is GLP certified for the bioanalysis of human and veterinary drugs (OECD category 8). There are no certifications applicable to the bioanalytical work performed in support of clinical trials. Any phase conducted in Charles River Saint-Nazaire is consistent with the principles of GCP. The existing GLP quality system is applied and additional due diligence is exercised to ensure the clinical trial subjects' rights are not compromised. This includes conducting clinical bioanalysis in accordance with SOPs based on ICH E6, EU Directive 2001/20/EC and EU Directive 2005/28/EC, the EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, and the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.
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Which types of companies has Saint-Nazaire worked with?
The site has already worked with different industries of all sizes, including agrochemical, pharmaceutical, biotechnology, clinical CROs, and cosmetics.
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What quality level do I need for bioanalysis of my molecule?
We advise and guide our clients on the best approach to be used based on the objectives of the nonclinical/clinical study together with the technical/scientific aspects. We suggest a panel of fit-for-purpose solutions from the non GLP research-grade assay to the GLP fully validated method.
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Can I use LC-MS/MS for my large molecule?
Yes, it is possible and will be determined on a case-by-case basis with your needs and our experts.
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Is there a lot of adaptation to do the bioanalysis from preclinical to clinical samples?
Our teams are trained to handle studies from both preclinical and clinical stages. Scientific expertise, instruments, and GLP environment are setup for preclinical studies provide an excellent framework for clinical sample analysis, with some additional specificities: our Site Procedures include requirements about patient safety and confidentiality; we are able to store a large volume of samples at -20°C/-70°C, with appropriate tools to manage them (Watson LIMS, barcode labels…); study follow-up includes in particular sample design reconciliation, data management (data transfer specifications, transfers), management of blinded studies in addition to bioanalytical plan and report deliveries.
