From Document Silos to Process Intelligence: A Multi-Layer Knowledge Graph for CMC Process Development

The paper introduces a modular agentic-AI platform that transforms heterogeneous CMC process-development documents into a dual-layer knowledge graph. The base layer creates a lexical Document‑Section‑Chunk hierarchy, while the intelligence layer extracts ontology‑aligned entities and links cross‑document concepts, all anchored by provenance. LLM agents navigate these layers to answer queries, and a novel three‑tier evaluation protocol demonstrates high retrieval‑augmented generation performance on proprietary data from a Sanofi program.

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