Detecting and characterizing immune responses to therapeutics is essential to assessing safety, understanding clinical impact and supporting confident decision-making across biopharmaceutical development. As programs progress through preclinical work, clinical trials and commercial monitoring, immunogenicity strategies must remain aligned with evolving regulatory expectations and the specific challenges of each therapeutic modality.
We deliver end-to-end immunogenicity solutions designed to evaluate immune responses to biologics, biosimilars and advanced therapies. Our services are designed and executed in alignment with FDA, EMA and ICH immunogenicity guidance, supporting submissions for IND, BLA and MAA filings.
Apply tiered ADA testing strategies to deliver sensitive detection, confirm specificity and characterize immune responses against your therapeutic.
Use cell-based and non-cell-based neutralizing antibody assays to evaluate impact on drug activity and inform clinical decisions.
Generate data compliant with FDA, EMA and ICH guidance to support IND, BLA and MAA filings.
Inform assay design, sampling schedules and interpretation frameworks through structured risk assessment and study design support.
Apply modality-specific approaches across biologics, biosimilars, cell and gene therapies and mRNA-based therapeutics.
Develop, validate and transfer assays with comparability assessments following method changes, supporting consistency from preclinical work through commercial monitoring.
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.
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.
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.
We develop, validate and maintain assays through their lifecycle in line with regulatory expectations, including method development and optimization, assay transfer, and full validation to GLP and GCP fit-for-purpose standards aligned with FDA and EMA expectations.
We integrate immunogenicity testing with our broader bioanalytical services, including pharmacokinetic (PK) and pharmacodynamic (PD) bioanalysis, biomarker analysis, cell-based bioassays and hybrid assays combining ligand-binding with LC-MS/MS.
We use modern analytical technologies for sensitive and reliable detection, including ligand-binding assays such as ELISA and ECL, cell-based assay systems and multiplex platforms.
As a world leader in pharmaceutical testing, inspection and certification, we deliver end-to-end immunogenicity capabilities aligned with FDA, EMA and ICH guidance. Our services are supported by modality-specific expertise across biologics, biosimilars, cell and gene therapies, mRNA-based therapeutics and viral vector platforms. Our integrated bioanalytical services enable a coordinated approach across PK/PD, biomarker and immunogenicity work.
Our global laboratory network combines validated methodologies with regulatory-ready data delivery, supporting submissions for IND, BLA and MAA filings while maintaining quality, compliance and data integrity across the development lifecycle.
Immunogenicity testing evaluates unwanted immune responses to therapeutics, including biologics, biosimilars and advanced therapies. Our end-to-end services are designed and executed in alignment with FDA, EMA and ICH immunogenicity guidance, helping detect, confirm and characterize immune responses across the product lifecycle.
This work supports safety assessment, clinical impact evaluation and regulatory submissions for IND, BLA and MAA filings.
A tiered approach to anti-drug antibody (ADA) testing is consistent with global regulatory guidance and is structured to ensure sensitive detection, specificity confirmation and robust characterization of immune responses. Our ADA assays follow this approach across:
We develop neutralizing antibody assays where clinically relevant to assess functional impact on drug activity and to support regulatory expectations for biologics and biosimilars. We provide both cell-based and non-cell-based NAb assays to support clinical and regulatory requirements.
Our immunogenicity services are tailored to address modality-specific challenges such as vector immunity, immune activation and durability of response. We support:
Our services are designed and executed in alignment with FDA, EMA and ICH immunogenicity guidance. Assays are developed and validated to GLP and GCP fit-for-purpose standards aligned with FDA and EMA expectations, supporting regulatory submissions for IND, BLA and MAA filings.
We develop, validate and maintain assays through their life cycle in line with evolving regulatory expectations. This includes method development and optimization, assay transfer and lifecycle management, and comparability assessments following method changes or transfers.
We use modern analytical technologies to support sensitive and reliable detection, including:
These platforms support both ADA and neutralizing antibody work, as well as integration with our broader bioanalytical capabilities.
Our immunogenicity testing is fully integrated with our broader bioanalytical services, including PK/PD bioanalysis, biomarker analysis, cell-based bioassays and hybrid assays combining ligand-binding with LC-MS/MS. This enables a coordinated analytical approach across a development program.