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Immunogenicity (IG) Simulator

Immunogenicity (IG) Simulator: A Platform Model to Predict Immunogenicity 

A QSP model for immunogenicity  

The Immunogenicity Simulator is a mechanistic QSP platform that predicts immunogenicity (IG) incidence and its impact on PK and PD. Immunogenicity (IG) is the ability of a molecule to induce an immune response to itself and further cause immunologically related adverse clinical events. The IG response typically shows up as the production of anti-drug antibodies or ADAs. However, a given ADA level may be manageable provided certain parameters are correctly optimized (e.g., dose, frequency, route of administration, target patient population, tolerability strategy, and co-medications). Optimizing these parameters for each drug quantitatively is possible using Quantitative Systems Pharmacology (QSP) modeling. A QSP-based approach can predict and better manage immunogenicity and guide clinical and regulatory decision-making in biologics drug development.  

Certara’s Immunogenicity Simulator is a state-of-the-art immunogenicity prediction tool that not only predicts the propensity of the compound to induce an immune response but also the full-time profile of PK and ADA concentration. This IG Simulator integrates various IG risk factors, quantitatively addressing the magnitude of the immune response and the impact, to simulate clinically relevant endpoints. This tool enables sponsors to run immunogenicity risk assessments and manage immunogenicity by adjusting the biologic dose, route of administration, patient population and/or co-medications.  

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 

Case Study with Roche

The IG Simulator has been validated with 25+ clinical case studies, including mono and combination therapies. The Simulator allows the creation of virtual patients and conducts virtual trials to analyze data in the same way as clinical data or biomarkers.  

We use a single-blinded evaluation with subject-level data from 10 monoclonals to assess the Immunogenicity Simulator’s credibility for application during the drug development process.  

Certara’s Vaccine Simulator  

The Certara QSP Vaccine Simulator provides dosing recommendations and answers key questions on efficacy and safety across multiple patient populations for COVID-19, oncology, and RSV.  

Desikan R, Padmanabhan P, Kierzek AM, van der Graaf PH. Mechanistic Models of COVID-19: Insights into Disease Progression, Vaccines, and Therapeutics. Int J Antimicrob Agents. 2022 Jul;60(1):106606. doi: 10.1016/j.ijantimicag.2022.106606. Epub 2022 May 16  

Meet the Expert

Rachel Rose, Senior Director, ABS

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 vaccines. 


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