ポスター：バイオプロセス開発向け構造化データ管理プラットフォーム

ESACT Edinburgh
June 23, 2024

Centralized structured data across multiple groups is critical for integrated bioprocess development with advanced data analytics, machine learning (ML) and artificial intelligence (AI) approaches, and efficient reporting to regulatory agencies.Growing adoption of high-throughput and process analytical technologies (PAT) and laboratory automation led to a substantial increase in the volume of data to be captured, processed, and analysed during bioprocess development. We showcase an E2E structured knowledge management platform that supports the entire bioprocess development workflow.The goal of bioprocess development is to generate robust processes to produce a biotherapeutic at desired quality and scale. We designed a data platform applicable to all proteins (e.g., IgGs, ADCs, bispecifics, enzymes), RNA & DNA therapeutics and vaccines (e.g., mRNA, DNA vaccines, ASOs), and cell and gene therapeutics (e.g., AAVs, CAR-T cells). In close collaboration with groups from leading biopharmaceutical and biotech companies, we validated the platform’s design for support of complete development workflows. The platform automates cell line development, assesses numerous scale-down upstream processes (USP), manages USP up-scaling, supports downstream process (DSP) development, and facilitates analytical and formulation development. It enables lineage tracking of all intermediates and batches. Analytical and process data, raw materials, equipment details, and molecule and cell line information are automatically tracked with the batches, enabling systematic assessment, robust process understanding, and quality risk management.The platform enhances process and product understanding and control. Having accumulated structured data can serve as a powerful foundation for learning, modeling, and data analytics, such as mechanistic modeling, ML and AI, to gain process knowledge and perform predictions.