Bioanalytical Services for Biotherapeutics and Small Molecules
Including Pharmacokinetics and Immunogenicity
Designed to be an extension of your laboratory, Nexelis, a Q² Solutions Company, supports bioanalysis in all phases with agile assay development to validation mindset. Whether we design a custom bioanalytical assay or support a client’s technology transfer, our method development process results in an optimized assay compliant with global standards. Our organization commits to continued investment and development in bioanalytical methods. Clients in the pharmaceutical, biotech, and animal health industries rely on us for the complete range of comprehensive bioanalytical services for all modalities.
From discovery bioanalysis to regulated bioanalytical work at our U.S. locations in Seattle and Indianapolis and our partner lab in Beijing, China, Nexelis provides a superior level of experience and scientific expertise. Here, you have access to leading scientific experts in liquid chromatography-mass spectrometry (LC-MS), high resolution LC-MS, ligand binding assays (LBA), and immunogenicity assays — including anti-drug antibody (ADA) and cell-based neutralizing antibody (nAb) assays. We have worked with over 80 different matrices across numerous species from biological fluids and tissues to cell media, with the capacity to scale to clinical.
- Globally recognized
- Top scientific team of collaborative problem-solvers
- One company for all your needs
- Discovery to clinical, end to end
- Phase-appropriate method development
- Early regulatory planning and phase-appropriate validation
- Multiple matrices and species
- Capacity to scale-up to clinical
Focus on Infectious Disease, Oncology, and Metabolic
Our agile and custom method development aligns your expectations, regulatory requirements, and a scientifically-sound optimization approach. We hold ourselves to the highest level of quality standards and comply with the latest regulatory standards, including the FDA’s and EMA’s most recent guidance of bioanalytical method validation.
We are dedicated to flexible, responsive support for your trial. Our team is ready to share their deep understanding of non-systemic matrices when you need to investigate site of action concentration, toxicity risk, blood-brain barrier permeability, or administration-route-specific parameters.
Innovative Paperless Solution: A Fully Integrated Electronic Lab Notebook
Our Indianapolis site (legacy company AIT Bioscience) is known for superior method quality in mass spectrometry and ligand binding assays, top scientific expertise, and responsiveness to clients’ needs. It was founded by industry veterans with 25+ years of experience in preclinical/exploratory bioanalysis and phase-appropriate validation and was named a Top 10 CRO for 2020 by Pharma Tech Outlook.
This site’s high efficiency, excellent communications, and transparency are due in part to its status as the world’s first paperless bioanalytical laboratory. A fully integrated electronic lab notebook (ELN) streamlines operations and incorporates real-time QC accountability into the entire workflow.
Bioanalysis and Immunogenicity Support for Metabolic and Orphan Diseases
Our credentials for bioanalytical work include: