Our experience will guide you in building reliable approaches to support the preclinical and clinical development of your vaccines and large molecules. Our dedicated team of experts will work in close collaboration with you to define the best way forward. Our team has an extensive Pharma and Biotech track record developing/transferring, qualifying and validating tests ranging from preclinical to clinical Phase I – IV.
Nexelis is constantly expanding its biomarker assay list by developing and validating assays for known and novel biomarkers. Many biomarker assays are readily available at Nexelis. Please scan the menu for your assay requirements.
In the vaccine field, since we are aware of the urgency to prevent or treat certain diseases, we have developed and qualified assays to support “FDA Fast Track designated vaccine developers” in their clinical trials.
- Chikungunya Micro-Plaque Reduction Neutralization Test (PRNT)
Throughput >240 samples per analyst per week
- Chikungunya ELISA
Throughput >320 samples per analyst per week
Vaccine-Focused Assays Currently Under Development:
- Zika Micro-Plaque Reduction Neutralization Test (PRNT)
- Zika ELISA
- Influenza pseudo-particle neutralization assay (various pandemic and seasonal strains)
Stay tuned for our upcoming developments in vaccines and bioanalytical.
With emerging infectious diseases and cancer trends comes an increasing demand for developing assays to support the new biological candidates up to market registration. We will customize assay development/transfer, qualification and validation based on your specific needs, in order to deliver stable and robust methods for reliable results.
In Vivo Model Development
We take advantage of our sustained knowledge of pros/cons to apply them to your project:
- Development imperatives
- Primary and secondary endpoint evaluation
- Candidate application
- Infection doses and routes
- Clinical readouts
- Immune readouts
- Administration route
- Immune system characteristics
- Specific considerations