ChabioTech has been selected for the Ministry of Science and ICT's 'AX (AI Transformation) One-Stop Voucher' support program. The company plans to implement a generative artificial intelligence (AI)-based manufacturing and quality control (CMC) regulatory document automation system to enhance the efficiency of cell therapy development and regulatory processes.
On July 27, ChabioTech announced that it is forming a consortium with Naver Cloud, Persona AI, and MediAI Plus to develop a software-as-a-service (AI-SaaS) platform aimed at accelerating the commercialization of generative AI-based cell therapies. The project will receive 2.6 billion won in government funding.
The AX One-Stop Voucher program aims to promote AI transformation among domestic companies by providing integrated support for AI solutions, cloud services, and data utilization in the form of vouchers.
In this initiative, Naver Cloud will provide high-performance cloud infrastructure, while Persona AI will be responsible for developing AI solutions and building the SaaS platform. MediAI Plus will handle data structuring and quality verification. The consortium aims to address delays in document and data processing throughout the entire cycle of cell therapy research and development.
CMC documents are critical regulatory documents that demonstrate the consistency, safety, reproducibility, and clinical applicability of a product during the cell therapy development process. Compiling and drafting these documents requires extensive time and manpower, as it involves integrating information from various departments, including manufacturing, quality, clinical, and non-clinical.
The AI-based application software being developed through this project will automate the creation and verification of CMC regulatory documents. This is expected to improve the efficiency of document searching, drafting, and review processes, enhance the quality of regulatory responses, secure competitiveness in global regulatory compliance, and shorten the timelines for new drug development and approvals.
ChabioTech plans to establish an integrated process that encompasses search, analysis, generation, and verification using four key validation agents and AI operations technology (AI Ops) to automatically perform document tasks and review procedures on behalf of users.
Yoon Seok-hwan, Executive Director of ChabioTech's AI team, stated, "We plan to structure dispersed document data to create an automated system that generates regulatory document drafts and conducts verification. We aim to demonstrate AI transformation in the regulatory document area, which requires high precision, such as in cell therapy CMC, and create a case that accelerates the spread of AX across the entire bio industry."
Meanwhile, ChabioTech is engaged in the research and development of cell and gene therapies (CGT) targeting intractable diseases such as cancer and rare diseases.
* This article has been translated by AI.
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