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Our Expertise
Having people’s health at heart, Nexelis contributes to saving lives by supporting pharmaceutical and biotech companies in the development of vaccines and large molecules.
Our dedicated team of scientists and versatile technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filing of blockbuster biologics, such as vaccines and complex large molecules.
We have established a strong reputation among the biopharma/biotech industry and regulatory bodies. With our deep scientific expertise, high-tech platforms and a broad range of instrumentation and automated systems, we can provide robust and innovative assays for fast and reliable preclinical and clinical immunological sample analysis.
150+ Dedicated scientists and analysts
100+ IND filings of new molecular entities
10+ years In bioanalytical & immunogenicity
15+ years In vaccines and immunotherapeutics
20+ years In preclinical models and immune read-outs
30+ years In biomarkers
250,000+ Results generated per year
150+ Validated biomarkers
Focus Area
We primarily focus on vaccines, large molecule bioanalysis, and biomarkers to support biologics innovations from preclinical to post-registration studies.
- Vaccines
Long industry experience in the development, qualification and validation of in vivo models and immunological assays, in single and multiplex formats, and sample testing to support vaccine development.
- Bioanalytical
Extensive experience in immunogenicity testing and in the fit-for-purpose biomarker development to support clinical trials with biomarker panels covering autoimmunity, oncology, and metabolic disorders as well as organ injuries.
Translational Sciences
- Ready-To-Use Assays
In supporting vaccine and biomarkers development, we have a growing menu of assays available and ready-to-use.
- Customized Development
At Nexelis, we customize assay development, qualification, and validation based on your specific needs to deliver robust methods for reliable results.
Assay Development and Technology Transfer
We work in close collaboration to transfer your immunological assays, to optimize existing assays to be aligned with regulatory requirements, and to increase the assay throughput, while monitoring the assay performance throughout the clinical trial testing.
- Assay Qualification and Validation Standards
At Nexelis, we have established and documented processes for qualifying/validating methods which are aligned with current industry and regulatory guidelines.
- Assay Transfer, Adaptation and Performance Monitoring
We can easily manage assay transfer of immunological assays, including viral and bacterial functional assays, as well as flow cytometry readouts.
- Assay Performance Monitoring
For delivering reliable clinical trial results, we know the importance of having a robust method that is consistent over time. Therefore, we monitor the assay performance throughout the clinical trial testing.
High-Throughput Testing
Nexelis offers you multiple automated systems for high-throughput analysis capabilities to support your project from early development through large clinical trials.
- Automated Liquid Handlers
Detection of immune markers in serum, plasma or cell culture supernatants.
- Automated Image Analyzers
Unique high-throughput image analysis systems allowing the determination of plaque-forming-units (PFU) or colony-forming-units (CFU).
- Specific Applications
Immunochemistry, virology, bacteriology.