FDA Licenses Certara’s Immunogenicity Simulator

Certara, a global leader in biosimulation, announced on Feb. 23, 2022 that FDA has licensed Certara’s Immunogenicity (IG) Simulator to research and evaluate immunogenicity in protein-based therapeutics. Certara’s IG Simulator can predict the immune response of therapeutics in development.

Immunogenicity is the tendency of a molecule to trigger an immune response. According to the press release, it is a major problem with protein-based therapeutics such as antibody-based drugs or biological medicines. Immunogenicity can be challenging to predict and can negatively impact drug development projects late in the process.

Certara’s IG Simulator is used to better understand and study immunogenicity of a wide range of biologics. Researchers will be able to utilize the Simulator in innovative ways, creating virtual patients and conducting computer-based trials. The IG Simulator has been validated in 20 clinical case studies, including mono and combination therapies.

“The FDA’s decision to license our IG Simulator affirms the importance of biosimulation for addressing the most important challenges in drug development,” said Piet van der Graaf, PharmD, PhD, senior vice president of Quantitative Systems Pharmacology (QSP) at Certara, in the press release. “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.”

Source: Certara