Hyperautomation company Persona AI has been selected for the Ministry of Science and ICT’s “AX (AI Transformation) One-Stop Voucher” support program and will launch the development of an AI agent-based platform that automates regulatory responses for cell therapies.

The project, with a total government support budget of KRW 2.6 billion, will be carried out by a consortium formed by CHA Biotech, Naver Cloud, and MediPlus. Its core objective is to accelerate AI transformation (AX) in the bioindustry, where development and regulatory approval procedures are highly complex, and to streamline cell therapy CMC (Chemistry, Manufacturing and Controls) regulatory response processes using AI.

As the lead company, Persona AI will develop a multi-agent SaaS platform that combines knowledge-based agents and document generation/validation agents with a CMC-specialized large language model (LLM). The platform will integrate and structure dispersed R&D and production data, and fully automate the entire workflow from drafting to reviewing and validating regulatory documents, thereby shortening new drug development and approval timelines and enhancing global regulatory response capabilities.

The roles among the consortium participants have also been clearly defined. CHA Biotech will conduct proof-of-concept of the platform in real-world cell therapy development and manufacturing environments; Naver Cloud will provide the cloud infrastructure; and MediPlus will build the data structuring and quality validation framework to ensure the reliability of AI training data.

Meanwhile, the Ministry of Science and ICT’s “AX One-Stop Voucher” is a government program that strengthens the competitiveness of domestic companies and promotes AI transformation across industries by providing integrated support for AI solutions, cloud infrastructure, and data utilization as a single package.

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