


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.
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We primarily focus on vaccines, large molecule bioanalysis, and biomarkers to support biologics innovations from preclinical to post-registration studies.
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.
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.
In supporting vaccine and biomarkers development, we have a growing menu of assays available and ready-to-use.
At Nexelis, we customize assay development, qualification, and validation based on your specific needs to deliver robust methods for reliable results.
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.
At Nexelis, we have established and documented processes for qualifying/validating methods which are aligned with current industry and regulatory guidelines.
We can easily manage assay transfer of immunological assays, including viral and bacterial functional assays, as well as flow cytometry readouts.
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.
Nexelis offers you multiple automated systems for high-throughput analysis capabilities to support your project from early development through large clinical trials.
Detection of immune markers in serum, plasma or cell culture supernatants.
Unique high-throughput image analysis systems allowing the determination of plaque-forming-units (PFU) or colony-forming-units (CFU).
Immunochemistry, virology, bacteriology.