Developing technology for predicting biopharmaceutical immunogenicity; integrating AI with non-animal testing methods (NAMs).
Cross-verifying AI predictive models against traditional testing methods to commercialize digital non-clinical CRO services.
HLB BioStep announced on the 13th that it will participate in a national project aimed at developing artificial intelligence-driven, non-animal testing methods (AI-NAMs) for the biopharmaceutical industry. The initiative is sponsored by the Ministry of Trade, Industry and Energy (MOTIE) and managed by the Korea Evaluation Institute of Industrial Technology (KEIT).
The project focuses on creating a digital non-clinical CRO system that utilizes data obtained from New Approach Methodologies (NAMs), such as microphysiological systems (MPS), combined with AI to predict the immunogenicity of biopharmaceuticals. Immunogenicity—the ability of a drug to provoke an immune response in the body—is a critical factor in evaluating the safety and efficacy of biological medicines.
HLB BioStep will be responsible for verifying the accuracy and practical applicability of immunogenicity prediction technologies utilizing AI and MPS, with the ultimate goal of integrating these capabilities into its commercial non-clinical CRO service offerings.
The company plans to first standardize existing immunogenicity testing methods that use human immune cells, and then confirm reliability by comparing these with MPS evaluation results. Additionally, the accuracy of the AI-driven predictive models will be refined by cross-referencing AI outputs with both traditional testing results and MPS data.
Subsequently, the consortium will validate the technology’s efficacy by conducting parallel assessments on actual antibody therapeutics using traditional, MPS, and AI-based methods. The final objective is to build a comprehensive digital non-clinical CRO service infrastructure that supports everything from immunogenicity risk prediction to results verification and final report generation.
The project involves a collaborative research effort between several institutions, including AI drug discovery firm Arontier, HLB BioStep, the Osong Medical Innovation Foundation, Chonnam National University, Euclidsoft, and Organoid Sciences.
“This project is significant in that it establishes a novel non-clinical evaluation framework using AI and moves toward translating that innovation into tangible commercial services,” said an official from HLB BioStep. “By successfully building these AI-based non-clinical CRO services, we aim to lead the new paradigm of non-clinical evaluation in the era of NAMs.”
