Services
Expert Immunogenicity Consulting for biotherapeutics, peptides, and oligonucleotides
We apply a risk-based approach to assess the impact of unwanted immune responses in treatment outcomes. Our goal is to generate a tailored immunogenicity risk assessment and fit-for-purpose bioanalytical strategy to each product and its therapeutic indication(s).
Our approach is based on sound scientific understanding of immunogenicity in drug development, regulatory expectations, and commercial priorities.
Our experience spans biosimilars, fusion and multi-domain proteins, cell & gene therapy, monoclonal antibodies (mAb), antibody-drug conjugates (ADC) and peptides (synthetic, recombinant, and generics).
Risk Identification
Risk-based assessment across development stages
We apply a structured, risk-based immunogenicity assessment to identify product- and patient-related factors that may drive unwanted immune responses. This supports informed decision-making from lead candidate selection through late-stage development.
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Intrinsic immunogenic potential (e.g. B-/T-cell epitopes, non-human motifs, allogeneic properties)
Mode of action and systems biology considerations
Product quality aspects: Expression system, DP formulation, and process-related risk factors
Manufacturing Changes and impact on Critical Quality Attributes (CQAs) (comparability exercises)
Subject-related factors, including genotypic and phenotypic variability
Dose regimen, route of administration, and implications for clinical study design
Risk prioritization aligned with product knowledge and regulatory expectations and development stage
Due diligence support for in-licensing opportunities
Risk Evaluation & Mitigation
From risk assessment to actionable development strategies
We translate immunogenicity risk assessment into practical evaluation and mitigation plans that support successful development and commercialization.
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Application of risk prediction tools (in silico, in vitro, ex vivo)
Integration of immunogenicity risk with product quality (CMC) aspects
Assessment of DS and DP CQAs in overall immunogenicity risk
Development and validation of bioanalytical methods (ADA, NAb, PK, immunophenotyping, PD markers)
Selection and control of critical reagents and positive controls
Data analysis strategies, including assay format selection, cut points, S/N analysis and pre-existing antibodies
Development of traslational “in vitro” assay protocols to derisk clinical development (e.g. cytokine release, hCD4 T cell proliferation assays, TLR activation)
Interpretation of non-clinical data to support progression into clinical development
Risk mitigation strategies and management of unexpected clinical findings
Participation in regulatory interactions in the EU (EMA and EU member states) and USA (FDA)
Assessment of Clinical Impact
Interpreting immune responses in clinical and regulatory context
We apply an integrated approach to assess the clinical relevance of immunogenicity for a balanced benefit–risk evaluation acceptable to regulators and prescribers.
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Prioritization of immunogenicity risks based on intended therapeutic use
Leveraging of severity of clinical signals, mitigation opportunities, and overall benefit–risk balance
Integration of humoral and cellular immune response data (ADA, ELISpot) with PK, PD, efficacy, and safety
Bridging immunogenicity data across CMC changes (e.g. manufacturing, formulation, presentation, devices)
Interpretation of confounding factors such as pre-existing antibodies, immune tolerance, and concomitant medication
Subject- and group-level analyses to assess worst-case clinical scenarios
Implications for prescribing information (e.g. USPI language) and ongoing risk management (e.g REMS)
Regulatory Strategy and High-Quality Submissions
Clear, integrated documentation for efficient regulatory review (EMA, FDA and other ICH regions)
We support the preparation of high-quality Immunogenicity Risk Assessments (IRA), Briefing documents, bioanalytical method reports, and Integrated Summary of Immunogenicity (ISI) for regulatory submissions that present immunogenicity data in a clear, consistent, and regulator-ready format across the product lifecycle.
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Interpretation of applicable regulatory guidance (ICH, WHO, EMA, FDA)
Immunogenicity Risk assessments (IRA) and strategies for clinical trial applications (CTA) in EU and USA (IND), and post-marketing changes in EU (variations ) and USA (supplements)
Bioanalytical documentation aligned with current regulatory and industry standards
Preparation for Scientific Advice and Advisory Committee meetings
Integrated Summary of Immunogenicity (ISI) for market applications (MAA, Generics, BLA, NDA, ANDA)
Support with regulatory interactions during meetings and review procedures