SERVICES

Integrated immunogenicity services across the product lifecycle

Immunogenicity Integrated® supports immunogenicity strategies across the product lifecycle, from candidate selection all the way to changes introduced to marketed drugs.

One advisory team driven by science-based evidence to meet regulatory and business expectations.

Our risk-based, solution-driven, and fit-for-purpose approach helps biotech and pharma companies and service providers to focus on the evidence needed for sound decisions and clear regulatory communication.

Immunogenicity & Immune Risk Assessment

Risk-based immunogenicity assessment across modalities and development stages

Immunogenicity risk assessment follows a scientific approach that weighs product-, process-, patient, and treatment-related factors, against clinical risk, development stage and regulatory expectations.

This approach adjusts the weight of each factor to each drug modality. The result is a clear focus on what drives the risk for a given product and supports fit-for-purpose analytical and mitigation strategies.

Areas of support

  • Immunogenicity Risk Assessments (IRA)

  • Integrated Summaries of Immunogenicity (ISI)

  • Adaptive and innate immune-response considerations

  • Non-clinical safety and toxicity evidence relevant to immunogenicity risk

  • Product quality attributes, formulation, and process-related risk factors

  • Risk prioritization, mitigation, and monitoring by development stage

  • Human-relevant and alternative methodologies, including New Approach Methodologies (NAM),

  • Due diligence for in-licensing, investment, and lifecycle decisions

Bioanalytical and immunogenicity testing strategy

Fit-for-purpose assay strategy for immunogenicity interpretation

A tailored risk assessment integrating product, patient, treatment, and mechanism-of-action factors defines a fit-for-purpose bioanalytical strategy to evaluate clinical relevance. Full assay validation is fueled by the severity of the identified risk.

This approach allows assessment of immune responses magnitude/persistence and neutralizing activity where relevant, alongside PK/PD/efficacy/safety.

Areas of support

  • ADA, NAb, PK, PD, biomarker, and immunophenotyping strategy

  • Assay development, troubleshooting, and interpretation support

  • Critical reagents, positive controls, sensitivity, specificity, selectivity, and drug tolerance

  • Cut point, threshold, signal-to-noise, singlicate, and alternative analysis approaches

  • One-tier, multiple-tier, and alternative testing-strategy evaluation

  • Small-volume, home-sampling, and decentralized-sampling considerations

  • Innate immune-activation strategy, including cytokine release, TLR activation, dendritic-cell activation, and danger-signal profiling

Immunogenicity Data Analysis & Clinical Relevance

Connecting immune response data to clinical relevance

The central aspect of the evaluation of immunogenicity is the clinical relevance in terms of patients' safety and efficacy in the context of PK/PD data.  

Areas of support

  • ADA/NAb data interpretation in the context of safety and efficacy outcomes

  • Domain specificity and immune-response characterization

  • Pre-existing antibodies and other confounding factors

  • Therapeutic Drug Monitoring and implications for dosing, where relevant

  • Integration of adaptive and innate immune-response data

  • Subject-level, treatment-group-level, longitudinal, and real-world interpretation

  • Clinical relevance and benefit–risk assessment

Regulated Bioanalysis

Strategic oversight of regulated bioanalytical data

Strategic oversight covers regulated bioanalysis planning, documentation, troubleshooting, and interpretation from early development through late-stage and post-approval studies. While laboratories generated the data, the data interpretation requires a mindful guidance and thorough evaluation.

Areas of support

  • Immunogenicity assay strategy

  • PK assay strategy

  • Soluble biomarker assay strategy

  • Cellular biomarker and immunophenotyping strategy

  • Cytokine-release and innate immune-assay strategy

  • Interpretation of regulated bioanalytical outputs

  • Alignment with risk assessments, Integrated Summaries of Immunogenicity, clinical study design, and regulatory submissions

Product Quality & CMC

Connecting product quality attributes to immunogenicity risk

Product quality attributes should be evaluated for their potential contribution to immunogenicity risk. These include the type and level of aggregates, product-related variants (e.g., clipped and non-glycosylated forms), and process-related impurities (e.g., host cell proteins, HCPs).

Because manufacturing changes can alter these attributes, they may increase the risk of clinical immunogenicity

Areas of support

  • Risk assessment of product- and process-related factors

  • Gap analysis of comparability exercises

  • Product quality changes in relation to immunogenicity, safety,  PK and efficacy

  • Immunogenicity strategy for biosimilars, generics, and complex products

  • Integration and design of NAMs for demonstration of sameness and biosimilarity

  • Lifecycle management and post-approval changes

  • Scientific justification of CMC decisions

Regulatory Strategy & Submissions

Regulatory support spans development stages, agency interactions, submission types, and post-approval changes.

Regulatory science principles are applied to the immunogenicity strategy, connecting scientific, bioanalytical, clinical, and product quality evidence into one clear scientifically sound narrative.

Areas of support

  • Immunogenicity Risk Assessments (IRA) and Integrated Summaries of Immunogenicity (ISI)

  • Regulatory submissions: IND, CTA, BLA, MAA, NDA, ANDA, and post-approval 

  • Health Authority meetings: FDA (INTERACT, pre-IND, End-of-Phase, pre-BLA), and EMA Scientific Advice

  • Briefing documents, company positions, and response strategies

  • Responses to health-authority questions during review procedures

  • Scientific justification of fit-for-purpose and alternative approaches

Experience across modalities

Collectively, the partners’ experience spans established and emerging therapeutic modalities, enabling a tailored strategy for each product.

Meet the team

  • Monoclonal, multispecific, and immune-cell-engaging antibodies, including antibody- and antigen-drug conjugates (ADC)

  • Recombinant proteins and enzyme-replacement therapies

  • Biosimilars, biobetters, follow-ons, and complex generics

  • Peptides and oligonucleotides

  • Cell and gene therapies, including AAV, CAR T-cell, allogeneic, and gene-edited iPS-cell therapies

  • mRNA-based therapeutics, viral vectors, genetically engineered bacteriophages, and other emerging modalities