At the core of the Katalyze platform is a 'dynamic context layer' that builds operation-specific ontologies and knowledge graphs for each molecule. This layer connects fragmented data across factories and labs via MCP (Model Context Protocol), command-line interfaces, and pre-built integrations (MES, LIMS, ELN, historians, SAP), creating a single source of truth. All agent decisions and insights are automatically anchored to immutable data sources, meeting GxP, data privacy, and data sovereignty requirements.
Key platform components include: the operational data layer (unified real-time data), master production records (GxP-native ontology layer), agent catalog (out-of-the-box domain agents for deviation investigations, CAPA tracking, APQR drafting, etc.), and agent studio (allowing internal scientists and engineers to build custom agents within a compliant framework). Sabya Dasgupta, Head of Global R&D Data Platform and Products at Sanofi, stated: 'Katalyze was built for enterprise needs from day one—the ontology layer is in place, and the data ingestion, security, governance, and deployment story is already solved.'