Certara’s Immunogenicity (IG) Simulator is a state-of-the-art Quantitative Systems Pharmacology (QSP) platform designed to predict immunogenicity incidence and its impact on pharmacokinetics (PK) and pharmacodynamics (PD). Immunogenicity, the ability of a molecule to trigger an immune response, can result in adverse clinical events, including the production of anti-drug antibodies (ADAs). By leveraging QSP modeling, this immunogenicity prediction tool enables drug developers to optimize critical parameters such as dose, frequency, and patient population to mitigate risks and enhance biologics development.
Immunogenicity Simulator
A cutting-edge tool to predict and manage immunogenicity
Learn more about the Immunogenicity Simulator
Validated with over 25 clinical case studies, including mono and combination therapies
Enables virtual patient creation and virtual trials for data analysis
Single-blinded evaluation conducted with subject-level data from 10 monoclonals
Features of the IG Simulator
Our immunogenicity prediction tool integrates various immunogenicity risk factors to simulate clinically relevant endpoints. This advanced tool quantitatively addresses immune response magnitude and impact, allowing sponsors to adjust biologic dose, route of administration, and patient population.
Modules of IG Simulator
- PBPK
- Bioinformatics (T cell epitope identification)
- Antigen presentation
- Immune cell transport (T cell, B cell, DC)
- Antibody circulation (IgG and IgM)
- Antibody affinity maturation
Drug modalities
- Protein biotherapeutics
- Potentially AAV therapeutics
QSPの専門家紹介
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エキスパート
Rachel Rose
Sr Director, QSP
Rachel has 15 years’ experience in developing QSP and PBPK/PD models for a broad range of drug modalities from small molecules to biotherapeutics including therapeutic proteins, antibody drug conjugates, gene therapies and vaccines. Her current work is focused on developing mechanistic models to predict immunogenicity of biotherapeutics and vacc...
専門家に相談する関連情報
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Certara offers Quantitative Systems Pharmacology (QSP) platform models across diverse therapeutic areas, enabling data-driven insights to accelerate drug development. 当社のカスタマイズされたソリューションは、複雑な生物学的システムを統合し、研究および臨床現場における科学的な意思決定をサポートします。
Speak to a QSP expert
Discover how Certara’s Immunogenicity Simulator can revolutionize your biologics development process.
Predict immunogenicity incidence with precision
Optimize dosing and patient population strategies
Leverage clinically validated modeling for informed decision-making
