Princeton Pharmaceutical Company Obtains FDA Approval for Immunogenicity Simulator

The U.S. Food and Drug Administration announced Wednesday that it has cleared Certara’s immunogenicity simulator to research and assess immunogenicity in protein-based therapies.

The Princeton-based leader in biosimulation IG simulator predicts the immune response of drugs in development, which is important for guiding clinical and regulatory decision-making.

“For five years, we have been investing, developing and validating our IG simulator with great rigor. We are excited about this opportunity to extend the impact of our simulator to rapidly assess immunogenicity risk, answer pressing questions, and guide study design for better clinical outcomes,” said Piet van der Graaf, Vice-President Senior President of Quantitative Systems Pharmacology at Certara.

Immunogenicity, or the tendency of a molecule to elicit an immune response, is a major issue with protein-based therapies such as antibody-based drugs or biologic drugs that are modified versions of natural human proteins. .

Immunogenicity has long been an area of ​​research for the FDA and biopharmaceutical companies because it can be difficult to predict and can negatively impact drug development projects late in the process, which can be costly to rectify. .

Certara’s IG simulator is used to assess, predict and manage the immunogenicity of a wide range of biological products, 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 from Certara’s IG QSP consortium. The IG Simulator has been validated in 20 clinical case studies, including monotherapies and combination therapies.

Comments are closed.