World Leader

What are you looking for? Loading component... Support biopharmaceutical safety and regulatory readiness - Detect and characterize immune responses Apply tiered ADA testing strategies to deliver sensitive detection, confirm specificity and characterize immune responses against your therapeutic. - Assess functional impact Use cell-based and non-cell-based neutralizing antibody assays to evaluate impact on drug activity and inform clinical decisions. - Align with global regulatory expectations Generate data compliant with FDA, EMA and ICH guidance to support IND, BLA and MAA filings. - Manage immunogenicity risk strategically Inform assay design, sampling schedules and interpretation frameworks through structured risk assessment and study design support. - Address complex therapeutic modalities Apply modality-specific approaches across biologics, biosimilars, cell and gene therapies and mRNA-based therapeutics. - Maintain assay performance across the lifecycle Develop, validate and transfer assays with comparability assessments following method changes, supporting consistency from preclinical work through commercial monitoring. Discover our immunogenicity services - Anti-drug antibody (ADA) testing We implement ADA assays using a tiered approach consistent with global regulatory guidance, including screening assays, confirmatory assays for specificity verification and ADA level determination. - Neutralizing antibody assays We develop cell-based and non-cell-based neutralizing antibody assays where clinically relevant, assessing functional impact on drug activity to support clinical and regulatory requirements for biologics and biosimilars. - Immunogenicity risk assessment and strategy We deliver immunogenicity risk assessment planning, study design support across preclinical and clinical phases, and tiered testing strategies aligned with regulatory guidance to support clinical safety evaluation and benefit-risk analysis....

How to apply

Online application form,Telephone

Tel: +31181693333