By offering a wide range of technologies such as MSD, ELISA, RIA and the cell-based iLite® technology platform, our offering includes method development, optimization, validation, and sample analysis – all performed in a modern LIMS environment according to GLP, GCP to ensure that regulatory requirements are met. We can also develop ligand-binding assays (LBA) for safety assessments, or to determine the mechanism of action of drug leads.
Through our parent company Svar Life Science we have access to a range of resources both in the form of technology and manpower. This means that we can scale up our business as required to meet project deadlines. Our goal is to provide key knowledge and analytical results, with more than 20 years’ experience in developing and running immunoassays and more than 250 immunology markers in our testing portfolio, we have the flexibility to adapt to many different studies to help our clients accelerate their drug development programs.
- We work according to ISO 17025 and Good Laboratory Practices (GLP)
- We are Good Clinical Practices (GCP) compliant
- We support clinical as well as pre-clinical studies
- We offer bioanalysis of biologics and biosimilars
- We perform biomarkers measurement services
- We offer in a multi-tiered approach to measure ADAs and NAbs
Our offering consists of:
- Bioanalysis – pharmacokinetic (PK) studies
- CMC support (potency assays – non GMP)
- Consultant services to optimize your study’s assay strategy and improve submission success
- Anti-drug antibody (ADA) and Neutralizing antibody (NAb) testing in • immunogenicity studies
- Cell-Based Neutralization Assays
We answer to your needs and our Bioanalytical Services can make a difference in your drug development project.