Development of biopharmaceutical immunogenicity prediction technology… Combination of AI and alternative animal testing methods
Comparison and verification of existing test methods and AI prediction results... Promoting commercialization of non-clinical CRO services
HLB Biostep participates in the development of biopharmaceutical evaluation technology that combines artificial intelligence (AI) and alternative animal testing methods. Through a national project, we will verify AI-based immunogenicity prediction technology and promote commercialization of digital non-clinical clinical trial contract organization (CRO) services.
HLB Biostep announced on the 13th that it will participate in the AI-NAMs national project for the bio-industrial technology development project promoted by the Ministry of Trade, Industry and Energy and in which the Korea Institute of Industrial Technology Planning and Evaluation (KEIT) participates as a specialized organization.
This project is to develop a digital non-clinical CRO system that predicts the immunogenicity of biopharmaceuticals using AI and data obtained through alternative animal testing methods (NAMs) such as microphysiological systems (MPS). Immunogenicity is a characteristic of a drug that induces an immune response in the body, and is a major factor in evaluating the safety and effectiveness of biopharmaceuticals.
HLB Biostep is responsible for verifying the accuracy and field applicability of immunogenicity prediction technology using AI and MPS and connecting it to actual non-clinical CRO services.
First, we standardize the existing immunogenicity test method using human immune cells and confirm its reliability by comparing it with the MPS evaluation results. We plan to improve the accuracy of the prediction model by comparing AI-predicted results with existing test and MPS data.
Afterwards, the effectiveness of the technology will be verified by combining existing testing methods, MPS, and AI-based evaluation on actual antibody drugs. Ultimately, we plan to establish a digital non-clinical CRO service system that supports everything from immunogenicity risk prediction to result verification and report writing.
In this project, AI new drug development company Arontier, HLB Biostep, Osong Advanced Medical Industry Promotion Foundation, Chonnam National University, Euclid Soft, and Organoid Science are participating as joint research and development organizations.
An official at HLB Biostep said, “This project is significant in that it establishes a new non-clinical evaluation system using AI and connects it to actual services.” He added, “We will lead the new non-clinical evaluation paradigm in the NAMs era by establishing an AI-based non-clinical CRO service in the future.”
