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Immunogenicity
Risks arising from the drug product molecular structure, its composition, mechanism of action (MoA), and its disposition are integrated to define a “fit-for-purpose” testing of immunological markers (i.e., anti-drug antibodies (ADA)).
Potential clinical interventions are also leveraged to mitigate the consequences of an unwanted immune responses to an otherwise highly efficacious therapeutic product (i.e. enzyme replacement, AAV-mediated gene therapy).
We apply the breath of knowledge accrued from the evaluation of immunogenicity of therapeutic proteins to the prediction, evaluation, and mitigation of unwanted immune responses to new product modalities (oligonucleotides, recombinant peptides, cell & gene therapy, bi-specific antibodies, antibody-drug conjugates)
Also visit: www.immunogenicityintegrated.com
Regulatory strategy
Identifying the relevant immune markers and the strategy for testing of clinical samples are founded on the product-specific immunogenicity risk assessment.
A life-cycle management approach to immunogenicity evaluation allows integration of accumulated knowledge into an optimal long-term safety monitoring.
An early risk assessment will constitute the basis for your future Integrated Summary of Immunogenicity (ISI).
Quality, preclinical, and clinical aspects weight into the immunogenicity potential of a biologic. Data integration is applied to define evidence-based testing of relevant markers but also to define clinical interventions to reduce adverse events.
The extent of the immunogenicity data collected during your phase 1, 2 and 3 trials are presented in an Integrated Summary of Immunogenicity (ISI). This regulatory document presents immunogenicity findings in the context of relevant treatment outcomes.
Integration of data
Translational approach
“In vitro” assays using human cells and humanized mouse models can be really informative during the development of biotherapeutics, recombinant peptides, and oligonucleotides.
Risk prioritization
Immunogenicity is all about identification of risks and their interpretation in the context of our immune system function.
How will the patients react to the administration of a new biotherapeutic will mostly depend on how it is “recognized” by their immune system.
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