Biologics and Biomarkers
Capabilities to support drug development of biologics at Accelera are provided by a dedicated Analytical Biology group, and encompass both Discovery Support & Development Support services.
- Multiple platforms available (ELISAs, AlphaLISA®)
Assay development, validation and sample analysis for pharmacokinetics- Fully validated, GLP (21 CFR part 11) compliant software and automated data analysis (WATSON LIMS)
- Validated pharmacodynamic & biomarker assays (flow cytometry)
- Cross-species immuno-safety assessment, including "cytokines storm" effects monitoring
- Anti-drug antibody response analysis capabilities
- Validated biomarker assays to support early clinical PoC, including set-up and validation of target-specific end-points measurements (PK/PD)