HLB BioStep to Use AI to Predict Immune Responses to Biopharmaceuticals

[Financial News] HLB BioStep is set to develop technology that uses artificial intelligence (AI) and animal alternative testing methods to predict immune responses to biopharmaceuticals. The company plans to apply the research findings in actual nonclinical trials and commercialize related services, expanding its AI-based contract research organization (CRO) business.
HLB BioStep announced on the 13th that it would participate in a national project on AI-based animal alternative testing methods (NAMs) under the Bioindustry Technology Development Program, which is being pursued by the Ministry of Trade, Industry and Energy, with the Korea Evaluation Institute of Industrial Technology (KEIT) serving as the specialized agency.
The project aims to use AI to predict the likelihood that biopharmaceuticals will trigger an immune response when administered to humans. If a drug ingredient triggers an immune response in the body, the drug may become less effective or cause side effects such as allergies. Assessing this in advance is important in nonclinical trials, which evaluate a drug’s safety.
The research team plans to develop and validate a system that uses AI to analyze data from microphysiological systems (MPS), antigen and antibody characteristics, and disease-related information to predict immunogenicity. MPS are systems that replicate in a laboratory the physiological characteristics of human organs or tissues and are used in testing methods that complement or replace animal testing.
HLB BioStep will be responsible for verifying whether the technology can be used in actual testing. First, it will standardize existing test methods using human immune cells and compare the results with MPS assessment results to verify their reliability. It also plans to compare AI predictions with results from existing tests and MPS assessments to obtain the data needed to improve predictive accuracy.
The company will then assess actual antibody drugs using existing test methods, MPS and AI, and verify whether the approach can be applied in practice. Based on this work, it plans to establish and commercialize a digital nonclinical CRO service that supports the process from immunogenicity risk prediction to result validation and report preparation.
The project’s joint research and development institutions include AI drug development company Arontier, HLB BioStep, the Osong Medical Innovation Foundation, Chonnam National University, Euclidsoft and Organoid Sciences.
An HLB BioStep representative said, “It is significant that we are establishing a new AI-based nonclinical evaluation framework and connecting it to actual services,” adding, “We will build AI-based nonclinical CRO services and respond to the era of animal alternative testing methods.”

[email protected] Jeong Sang-hee Reporter