Boston — Emulate, Inc., a provider of Organ-on-a-Chip technology, said it has submitted a full qualification package to the U.S. Food and Drug Administration for its Human Liver-Chip under the agency’s Innovative Science and Technology Approaches for New Drugs, or ISTAND, program.
The submission advances Emulate’s effort to qualify the Human Liver-Chip as a Drug Development Tool for assessing drug-induced liver injury.
The package includes data generated using both Emulate’s Zoë Culture Module and its newer AVA Emulation System. If qualified by the FDA, the Human Liver-Chip could provide drug developers with a standardized human-relevant method for evaluating liver toxicity.
“Submitting this qualification package represents years of close collaboration with the FDA and reflects the maturity of Organ-on-a-Chip technology as a practical tool for drug development,” said Jim Corbett, Chief Executive Officer of Emulate. “Our application has been strengthened and shaped by the FDA reviewers’ comments and questions throughout the Letter of Intent and Qualification Plan stages, helping us develop a robust evidence package to support qualification. As the industry continues shifting toward more human-relevant approaches, we’re proud to help drive that progress with technology designed to inform clearer, more confident preclinical decision-making.”
According to Emulate, the qualification package includes data showing reproducibility across three independent laboratories and three primary human hepatocyte donors. The company also reported that the Liver-Chip consistently distinguished between structurally similar compounds with different liver toxicity profiles and produced consistent results in studies conducted months apart.
The package also includes data from the AVA Emulation System, which can support up to 96 independent Organ-Chip samples per run. Emulate said the higher-throughput platform could help expand use of the technology across pharmaceutical research and development.
“The strength of this submission is not simply that the Liver-Chip works, it’s that it works consistently,” said Lorna Ewart, Ph.D., Chief Scientific Officer of Emulate. “The data show reproducibility across laboratories, multiple cell donors, and studies conducted months apart, which are exactly the characteristics regulators and industry need to trust a new Drug Development Tool. Including AVA in the qualification package also extends that confidence to a platform designed for larger-scale studies, making it a realistic tool to incorporate in standard pharmaceutical workflows.”
The submission builds on previous collaboration between Emulate and the FDA involving Liver-Chip research and methods for interpreting results. The company said reaching the final stage of the ISTAND qualification process is part of broader efforts to expand use of human-relevant testing methods in drug development and reduce reliance on animal testing.
