Persona AI to develop AI platform for cell therapy regulatory automation with 2.6 billion won government backing

Persona AI, a hyperautomation company, will lead the development of an AI-driven platform designed to automate Chemistry, Manufacturing, and Controls (CMC) processes for cell therapies. This initiative is supported by a 2.6 billion won government grant through the Ministry of Science and ICT's 'AX (AI Transformation) One-Stop Voucher' program. The project is a collaborative effort involving CHA Bio-Group, Naver Cloud, and Medi-i-plus, aiming to accelerate AI adoption within the demanding biopharmaceutical sector. The core objective is to enhance the efficiency of regulatory compliance for cell therapies by leveraging AI. Persona AI will spearhead the creation of a Software-as-a-Service (SaaS) platform. This platform will feature a multi-agent structure, combining a large language model (LLM) specialized in CMC with knowledge-based agents and document generation/verification agents. The goal is to integrate and structure scattered research and production data, automate the entire process from regulatory document creation to review and verification, thereby shortening drug development and approval periods and boosting global regulatory competitiveness. Each consortium member has defined roles to ensure the project's success. CHA Bio-Group will provide a real-world cell therapy development and production environment for platform validation. Naver Cloud will supply the necessary cloud infrastructure, while Medi-i-plus will establish a framework for structuring training data and ensuring its quality, thereby guaranteeing the reliability of the AI data. The government's 'AX One-Stop Voucher' program is designed to support domestic companies by providing integrated packages of AI solutions, cloud infrastructure, and data utilization services, fostering competitiveness across industries. This project signifies a major step towards digital transformation in the biopharmaceutical field. By automating complex and time-consuming CMC processes, the platform is expected to significantly reduce the burden on researchers and developers. This will not only expedite the delivery of innovative cell therapies to patients but also enhance South Korea's position in the global biopharmaceutical market. The collaboration underscores a strategic move to harness AI for overcoming industry-specific challenges and driving innovation.