ポスター：デジタル化によるワクチンプロセス開発のイノベーション

February 15, 2023

Translating a procedure that is used to make a vaccine in a research laboratory to a process that can be scaled up and run reproducibly in a manufacturing plant is challenging. Depending on the vaccine format, it includes development of a stable cell-based expression system that produces large quantities of the product, optimization of the fermentation process, cell harvesting and disruption, debris removal, and purification. Analytical methods must be developed for characterization of each step and to quantify potency, purity, and stability. Innovation of vaccine process development through digitalization provides a significant competitive edge due to a broad array of benefits, including reduced costs and time to market. The Genedata knowledge management platform digitalizes vaccine research and process development end-to-end. The platform is suitable for all vaccine formats, enables maximum automation and data integrity, and is an essential foundation for AI/ML and digital modeling. In this poster, we spotlight Genedata Bioprocess^® and show we how it streamlines vaccine process development including cell line development, USP, DSP and formulation development, and analytics development.