U.S. FDA Licenses Certara’s Immunogenicity Simulator
“The FDA’s decision to license our IG Simulator affirms the importance of biosimulation for addressing the most important challenges in drug development,” said
Immunogenicity, or the tendency of a molecule to trigger an immune response, is a major problem with protein-based therapeutics such as antibody-based drugs or biological medicines that are engineered versions of naturally occurring human proteins. Immunogenicity has long been an area of keen research interest by the FDA and biopharmaceutical companies as it can be challenging to predict and can negatively impact drug development projects late in the process that may be costly to rectify. As a part of its pilot model-informed drug development (MIDD) program, the FDA held a workshop on immunogenicity in June of 2021 with more than 2,000 registrants, where
Certara’s IG Simulator is used to assess, predict and manage immunogenicity of a wide range of biologics, including monoclonal antibodies, bi-and multi-specifics and cell and gene therapies. Using the Simulator, researchers can create virtual patients and conduct computer-based trials. The IG Simulator was developed in partnership with eight leading pharmaceutical companies in Certara’s
To learn more about the IG Simulator, please visit https://www.certara.com/software/quantitative-systems-pharmacology/.
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Source: Certara