Supporting drug development programs
As an integral part of Euro Diagnostica, Wieslab Bioanalytical CRO Services offer ISO 17025, GCP and GLP compliant services supporting the drug development process through a range of services and expertise for non-clinical as well as clinical studies for pharma, biotech and CRO customers.
At the Sweden-based laboratory deep knowledge from clinical diagnostic testing in immune-mediated diseases is combined with novel technologies and scientific expertise in immunological interactions. We test and validate a wide range of assays for sensitive and specific quantitation of biological drugs.
Wieslab Bioanalytical Services focuses on selected areas within bioanalytical laboratory services; in particular large molecules (biologics and biosimilars) within immune-mediated diseases and non-clinical as well as phase I – III clinical studies.
Bioanalytical Services highlights
- Bioanalytical laboratory services according to ISO 17025, GCP and GLP
- Support for clinical as well as non-clinical studies
- Scientists experienced in developing and validating assays according to relevant guidelines
- Expertise in various different technologies and methods
- Key areas
- Bioanalysis of biotherapeutics and biosimilars
- Immunogenicity studies: ADA – screening and confirmatory assays (ELISA, RIA and cell-based)
- Bioanalysis – pharmacokinetic (PK) studies
- CMC support for lot release of drugs
- Consultant services to optimize your study and submission success
Cell-based and ligand-binding assay services
- Reporter gene cell-based assays
- Enzyme-linked Immunosorbent Assays (ELISA) in various formats
- Meso Scale Discovery (MSD) Electrochemiluminescence (ECL)
- Neutralizing Antibody assays
- Enzyme immunoassay (EIA) including Acid Dissociation (AD)
- Radioimmunoassays (RIA)
At Wieslab Bioanalytical Services we use kits or applications from Euro Diagnostica and iLite® technology, or other providers when applicable. We also offer method development and validation. Our knowledge base within clinical diagnostics, immunoassay development and bioanalytical GLP compliant lab services gives you an expert partner with a comprehensive understanding of your project and the knowledge to help accelerate your drug development project forward.