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.

Discovery Support:

• Assay-specific reagents production (antibody fragments by phage display, generation of cleaved antibody fragments, oligonucleotides)
• Cell-based assays for Mechanism of Action studies and early biomarker identification
• Screening for cross-reactivity on tissues
• Multiple platforms available (ELISAs, Hybridization assays, RT-qPCR, protein arrays)

Development Support:

• 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, multiplexing protein arrays)
• Cross-species immuno-safety assessment, including. "cytokines storm" effects monitoring
• Anti-drug antibody response analysis capabilities (semi-quantitative receptor binding assays, FACS, qELISA)
• Validated biomarker assays to support early clinical PoC, including set-up and validation of target-specific end-points measurements (PK/PD)

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