We are an immunology-centric CRO specialized in preclinical models and clinical assay development in single and multiplex formats and sample analysis for low-, mid- and large-scale clinical testing.
Our versatile team of scientists and technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filings of over 100 new molecular entities, including blockbuster biologics such as vaccines and complex large molecules.
The ever-growing demand for techniques to assess humoral, innate, and cell-mediated immunity induced by candidate vaccines and immunotherapies is met by Nexelis. We proudly provide superior immunological services that are client-centric and can be tailored to meet expedited timelines.
We are recognized for our scalable operational model resulting in optimal flexibility for our clients and high throughput capabilities for supporting large, global studies.
With services in molecular biology, protein expression, protein purification and structural/physicochemical characterization, we can optimize your antigens to improve immunoassay efficiency and reproducibility, adapt them to the desired throughput, multiplexing, or other innovative technologies.
- Molecular Biology
Nexelis offers tailored recombinant DNA services according to your specific requirements, including gene synthesis with codon optimization, construct design, molecular cloning, mutagenesis, endotoxin-free plasmid isolation and DNA sequence verification.
Our Protein Sciences experts use recombinant protein expression technology for protein production using recombinant DNA.
The Nexelis scientific team has extensive experience in the development and optimization of purification strategies using multiple chromatographic steps.
The Nexelis protein characterization platform provides a comprehensive range of high-quality analytical assays to ensure the identity, purity and physicochemical properties of the protein of interest.
Nexelis develops single and multiplex immunochemistry assays for preclinical and clinical use while working in close collaboration with clients to adapt, develop, qualify and validate specific tests to quantify humoral and cellular responses elicited by vaccines and immunotherapies.
At Nexelis, we develop viral and bacterial manual and automated functional assays to evaluate the level of neutralizing antibodies generated in vaccine trials. Our experts will adapt, develop, qualify and validate functional assays as per your needs.
Our experts develop cellular immunology assays to monitor immune cells during preclinical studies or clinical trials for the assessment of immunogenicity or efficacy of candidates from early to late-stage development. We will support you in appropriately assessing cell-mediated immune responses and phenotyping.
Our services in immunogenicity and fit-for-purpose biomarkers will support pharmaceutical and biotech industries through all phases of assay development/transfer, validation and testing to take your large molecule candidate from preclinical to clinical programs (Phase I-IV) using state-of-the-art platforms.
- Pharmacokinetic Testing
We have a deep understanding of the regulatory expectations and intricacies in developing these types of methods. We will work with you to optimize and validate the assay to be ready for sample testing.
- Immunogenicity Testing
Immunogenicity assays are used to detect anti-drug antibodies (ADAs) that specifically bind to the therapeutic protein product.
- Fit-For-Purpose Biomarkers
We have experience in such areas as cardiovascular risk, metabolic diseases, chronic liver disease, drug induced liver injury, acute kidney injury, musculoskeletal, and inflammation.
Nexelis provides one-stop-shop solutions for biomarkers services in inflammation and immunology, oncology, cardiovascular/metabolic diseases, organ injuries and nutritional health.
Our assay menus are offered in both alphabetical and category-based formats.
Our preclinical in vivo models, adaptable to your needs, will support the development of multiple candidates such as vaccines or other biologically-active molecules.
- Animal Study Design
We offer key-in-hand services from need evaluation and study design to project management and study execution.
- In Vivo Study Approaches
Immunogenicity, efficacy, reactogenicity, polyclonal and monoclonal antibody generation.
- Study Readouts
Viral and bacterial load measurements, tumor growth, clinical readouts & many more…