Assay Development, Qualification, and Validation
- Technical experts in custom assay design, development, method adaptation and technology transfer of immunological assays, including viral and bacterial functional assays, and flow cytometry readouts.
Immunological Sample Testing
- Available high-throughput testing (liquid handlers and automated readers), rapid data analysis, biostats, and interim and final reports.
- Sample analysis available for exploratory studies, mid-scale studies for preclinical and Phase I, and large-scale studies for Phase II to post-marketing studies.
- Capacity of generating over 250K results annually, ensuring efficient support of large clinical studies, including post-licensure trials.
Bioanalytical and Biomarker Testing Services
- Unique position with the ability to develop, validate and customize assays in-house.
- Over 150 fully CLIA validated assays and an extensive network of scientific, regulatory, and technology expertise.
Protein Optimization Services
- Different bacterial and eukaryotic expression systems are available for protein design and expression optimization, generation and selection of stable cell lines, and characterization of protein biophysical properties.
Project Consultancy and Management
- Strong scientific project managers supporting the development and adaptation of immunoassays based on specific needs.
- Close personal, collaborative, and optimal interactions with our partners.
- A single and dedicated project manager is assigned to each of our partners’ projects to ensure the best communication, timeline follow-up, and quality.
Sample Management
- Support of testing laboratories, including logistics, methods of collection, shipping and receiving, preparation, and storage with the highest level of quality.
- Capacity to store over 1,000,000 samples.
- Web-based LIMS system in place to monitor quality, from reception to final testing, to ensure secured data protection, efficiency and quality in sample management, tracking, and associated data.
Highest Quality Standards
- Across all our operations, testing procedures, and reporting.
- Well-established quality management systems (QMS) supported by procedures in accordance with applicable GCP/GLP/GCLP regulations and guidelines.