Princeton pharma company gets FDA nod for its Immunogenicity Simulator

Affirms Certara’s advancements of innovative biosimulation technology and its growing impact in R&D

The U.S. Food and Drug Administration on Wednesday announced it licensed Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

The Princeton-based leader in biosimulation’s IG Simulator predicts the immune response of drugs in development, which is important to guide clinical and regulatory decision-making.

“For the past five years, we have invested, developed and validated our IG Simulator with a high level of rigor. We are excited by this opportunity to expand the impact of our simulator to quickly assess immunogenicity risk, addressing pressing questions and guiding study design for better clinical outcomes,” Piet van der Graaf, senior vice president of quantitative systems pharmacology at Certara, 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.

Certara’s IG Simulator is used to assess, predict and manage immunogenicity of a wide range of biologics, including monoclonal antibodies, bi-and multispecifics 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 IG QSP Consortium. The IG Simulator has been validated in 20 clinical case studies, including mono and combination therapies.