From Document Silos to Process Intelligence: A Multi-Layer Knowledge Graph for CMC Process Development
Updated 2 h ago · first seen 12 Sept 2026
paper_01M29X34NKGJ8RG2WEQY5RFGGG
- Published
- 12 Sept 2026
- T1 · 2 h ago
- arXiv
- 2609.11493
- T1 · 2 h ago
- Category
- cs.AI
- T1 · 2 h ago
Abstract
Chemistry, Manufacturing and Controls (CMC) process development generates an enormous body of technical information across a multi-stage, knowledge-intensive continuum from drug discovery to commercial manufacturing. This knowledge is traditionally fragmented across functions and heterogeneous formats, causing traceability gaps and significant knowledge-management costs during technology transfer and regulatory filing. We present a modular agentic-AI platform that converts a heterogeneous corpus of process-development documents into a queryable, dual-layer knowledge graph. A base knowledge layer builds a lexical graph with a Document-Section-Chunk hierarchy through lossless ingestion of digital, scanned, handwritten, and multilingual documents, while an intelligence layer extracts ontology-aligned entities and bridges cross-document concepts through a provenance-anchored domain graph. LLM agents operate across both layers, selecting the retrieval path best suited to each question. We evaluate the lexical layer with a novel three-tier protocol measuring the deployment-fidelity of a retrieval-augmented generation (RAG) system on proprietary data, demonstrated on 505 questions curated from 38 development reports of a Sanofi small-molecule program. Tier-1 multiple-choice accuracy of 95% signals strong platform reliability; the stricter Tier-2 LLM-judge pass rate of 85%, which degrades on comparative and corpus-wide questions, reveals a failure taxonomy that Tier-1 accuracy alone fails to capture. A router agent selects between layers according to question type. We anticipate this protocol will enable future designers of agentic platforms to assess their systems against nonpublic databases, and that graph-based architectures will see broader adoption in pharma as a means of transforming fragmented document repositories into structured process intelligence.
Authors 3
Faryad Sahneh, Reza Amirmoshiri, Yasser Jangjou
Specification
- Official page
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
- Arxiv announce type
- new
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
- arXiv id
- 2609.11493
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
- Categories
- cs.AI, cs.MA
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
- Primary category
- cs.AI
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
- Published
- 12 Sept 2026
Source:arXiv (Atom API + RSS)T1observed 2 h agohigh
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Provenance
Attributed facts
9
Source tiers
T19
Freshest observation
2 h ago
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- Authors
- Reza Amirmoshiri, Faryad Sahneh, Yasser Jangjou
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Claim history · Abstract
Abstractabstract1
| Value | Valid from → to | Status | Source | Confidence | Extractor |
|---|---|---|---|---|---|
| Chemistry, Manufacturing and Controls (CMC) process development generates an enormous body of technical information across a multi-stage, knowledge-intensive continuum from drug discovery to commercial manufacturing. This knowledge is traditionally fragmented across functions and heterogeneous formats, causing traceability gaps and significant knowledge-management costs during technology transfer and regulatory filing. We present a modular agentic-AI platform that converts a heterogeneous corpus of process-development documents into a queryable, dual-layer knowledge graph. A base knowledge layer builds a lexical graph with a Document-Section-Chunk hierarchy through lossless ingestion of digital, scanned, handwritten, and multilingual documents, while an intelligence layer extracts ontology-aligned entities and bridges cross-document concepts through a provenance-anchored domain graph. LLM agents operate across both layers, selecting the retrieval path best suited to each question. We evaluate the lexical layer with a novel three-tier protocol measuring the deployment-fidelity of a retrieval-augmented generation (RAG) system on proprietary data, demonstrated on 505 questions curated from 38 development reports of a Sanofi small-molecule program. Tier-1 multiple-choice accuracy of 95% signals strong platform reliability; the stricter Tier-2 LLM-judge pass rate of 85%, which degrades on comparative and corpus-wide questions, reveals a failure taxonomy that Tier-1 accuracy alone fails to capture. A router agent selects between layers according to question type. We anticipate this protocol will enable future designers of agentic platforms to assess their systems against nonpublic databases, and that graph-based architectures will see broader adoption in pharma as a means of transforming fragmented document repositories into structured process intelligence. | → current | current | arXiv (Atom API + RSS)T1 | high | deterministic |
Claims are temporal and append-only: a new observation closes the previous claim (valid_to) instead of overwriting it. Conflicting claims from different sources are kept side by side and flagged — never averaged. Methodology →
- New paperPaperFrom Document Silos to Process Intelligence: A Multi-Layer Knowledge Graph for CMC Process Development
New paper: From Document Silos to Process Intelligence: A Multi-Layer Knowledge Graph for CMC Process Development
arxiv
| Source | Document | Type | Tier | Last observed | Snapshots |
|---|---|---|---|---|---|
| arXiv (Atom API + RSS) | rss.arxiv.org/rss/cs.AI | feed | T1· Official | 2 h ago | 2 |
Tier 1 = official/primary, 2 = quality secondary, 3 = community, 4 = unverified. Every snapshot is archived; see all sources and the methodology.