Saint-Nazaire: Bioanalysis, Biomarkers, and Immunogenicity

When choosing a partner, you need to consider their depth of scientific expertise, infrastructure, and program management skills. Our site in Saint-Nazaire, France has everything you need to run bioanalytical studies to evaluate preclinical and clinical drug candidates. No matter what modality you are using or therapeutic area your research is working on, we can accommodate your specifications and timelines.

Talk with Our Team

Photo of the Saint-Nazaire site.

Preclinical 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.


See What Saint Nazaire Can Do for You

 

Facility overview of the Saint-Nazaire site with details of their bioanalysis, biomarker, and immunogenicity capacities.

Located just outside of Nantes, France, our Saint-Nazaire site can perform small and larger molecule and biomarker bioanalysis to support clinical and nonclinical studies (discovery up to Phase III/IV clinical trials).

See Our Capabilities

 

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 human or animal matrices (e.g., plasma, excreta, bile, tears, CSF, tissues, etc.).

Large Molecules

For large molecules, bioanalysis assays are run by immunoassay or liquid chromatography-mass spectrometry (LC-MS/MS).

By Immunoassay

More than 30 ligand-binding assays using several techniques (ELISA, ECLIA, RIA, etc.) are developed each year to identify peptides, proteins, monoclonal and multifunctional antibodies, biosimilars/biobetters, or antibody-drug conjugates (ADC) in several matrices. Our 12 scientists will make sure they find a technique suited for your bioanalysis project(s).

The team at Saint-Nazaire has conducted more than 60 studies annually and analysed more than 20,000 samples per year, so we have the capacity to take on your project and get the crucial data you need to make more confident go/no-go decisions.

By LCMS/MS

This bioanalysis technique identified the presence of peptides, proteins, monoclonal, ADC, and oligonucleotides by performing a quantitative measurement and characterization (e.g., peptide mapping and modification identification).

Our experienced team can prepare fit-for-purpose samples using ImmunoCapture/Affinity, tryptic digestion, and Intact, followed by LC-MS or high resolution mass spectrometry (HR-MS).

 

Small Molecules

For your small molecule development, it is important to run the most sensitive and robust assays available. The following equipment allow us to reach those key points for analysis of active compounds and metabolites in various biological matrices (plasma, urine, tissues…):

  •    Automated and fit-for-purpose sample preparation (Protein crash, LLE, SPE…)
  •    Last generation LC-MS/MS (ABSciex API6500)
  •    High resolution mass spectrometry (HR-MS)
  •    GC/MS

With more than 70 validations conducted and 70,000 samples analyzed annually, Saint-Nazaire is ready to take on your bioanalytics testing.

Read More on Bioanalytics

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, ImmunoCAP [Phadia], LC-MS, HR-MS), Saint-Nazaire will be able to identify your soluble biomarkers (in single and MultiPlex PCR) 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

Read More on Biomarkers

Saint-Nazaire can determine the presence of antibodies generated against the drug at all stages of the development process. The different steps that can be run after the development and validation of controls from screening assay to neutralizing assay are shown below.

Schema of antibody testing, where the whole process can be run together or as stand-alone steps.

Our team analyzes over 9,000 samples annually and conducts more than 40 studies, from simple screening to titration and neutralizing steps.

Read More on Immunogenicity

 

Frequently Asked Questions (FAQs) About the Saint-Nazaire Facility

Talk to Our Team

 

Related Resources