Legend Biotech is a global biopharmaceutical company focused on cell and gene therapies, operating in a highly controlled manufacturing environment. To maintain compliance and product quality, the company tracks and investigates manufacturing deviations. Although many of these are minor and follow familiar patterns, each one must be reviewed and documented in full. To reduce repetitive effort and improve response time, Legend Biotech launched an initiative to support its quality teams with AI-powered tools capable of surfacing relevant historical cases and assisting with analysis and reporting.
Ellion and Sagacify partnered to propose and lead an initiative supporting Legend Biotech in improving the handling of deviations. Ellion brought pharmaceutical domain expertise, while Sagacify focused on the technical development. The collaboration involved creating a knowledge graph and developing a pipeline for an AI assistant capable of retrieving relevant past cases and supporting investigations. The project was delivered as a proof of concept, focused on demonstrating impact on a targeted set of deviation cases.
The proof of concept combined several AI components to assist investigators in managing manufacturing deviations more efficiently. Central to the system was a retrieval-based assistant capable of identifying similar past cases using a hybrid of keyword and semantic search. Historical reports were structured into a knowledge graph, enabling precise comparisons across incidents and streamlining access to institutional knowledge.
The solution included:
Each step of the process required human validation to ensure alignment with pharmaceutical compliance requirements.
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