HLB BioStep is carrying out a national project on New Approach Methodologies (NAMs) commissioned by the Ministry of Trade, Industry and Energy.


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According to HLB BioStep on October 13, the project aims to develop and validate a digital preclinical contract research organization (CRO) system that uses data based on microphysiological systems (MPS) to comprehensively analyze various factors, including antigen and antibody characteristics and disease features, and uses AI to predict the immunogenicity of biopharmaceuticals. AronTIER, Osong Medical Innovation Foundation, Chonnam National University, Euclidsoft, and Organoid Sciences are participating as joint research and development institutions.


HLB BioStep will verify whether immunogenicity prediction technology using AI and microphysiological systems (MPS) can be applied in actual preclinical studies, and will commercialize the technology as a preclinical CRO service.


First, the company will standardize existing immunogenicity testing methods that use human immune cells, then compare the results of existing tests with MPS assessments to verify their reliability. It will also compare and analyze AI predictions against the results of existing tests and MPS assessments, providing data needed to improve the accuracy of AI models. In addition, it will evaluate actual antibody drugs using existing testing methods, MPS, and AI-based assessments to verify their feasibility for practical use. Based on this work, the company plans to establish and commercialize a digital preclinical CRO service model that supports the process from predicting immunogenicity risks and validating results to preparing reports.



An HLB BioStep representative said, "This project is significant because it will establish a new AI-enabled preclinical assessment system and turn it into an actual service. We will build AI-based preclinical CRO services and lead a new paradigm in preclinical assessment in the era of NAMs."


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