Rajan Bastakoti

Sagar Bhetwal, Rajan Bastakoti, Nirajan Acharya et al.

Biopharmaceutical manufacturing organizations operate under regulatory frameworks such as FDA guidance, EU Good Manufacturing Practice (GMP), and the EU AI Act, which can restrict the use of cloud-based artificial intelligence systems. Locally deployed large language models (LLMs) offer a privacy-preserving alternative, but their suitability for pharmaceutical manufacturing tasks remains underexplored. This study evaluates four open-source LLMs (Qwen 2.5 Coder 7B, Llama 3.1 8B, Mistral 7B, and Meditron 7B) deployed locally via Ollama for natural-language-to-SQL generation over a pharmaceutical manufacturing database. A FastAPI-based evaluation platform, PharmaBatchDB AI, was developed using a synthetic Microsoft SQL Server database containing approximately 63,000 records across Batch, Manufacturing Execution System (MES), and Clean-In-Place (CIP) modules. Models were benchmarked on 60 domain-specific natural-language questions using metrics including SQL extraction rate, SQL compliance, factual consistency, ROUGE-L, hallucination rate, throughput, and latency. Qwen 2.5 Coder 7B, Llama 3.1 8B, and Mistral 7B generated SQL for all evaluation tasks, while Meditron 7B failed on nearly all tasks due to context-window limitations and poor SQL generation capability. Llama 3.1 8B achieved the highest SQL compliance, whereas Qwen 2.5 Coder 7B achieved the strongest overall text similarity and factual consistency. Performance differences between the two leading models were not statistically significant. The results show that code-tuned general-purpose LLMs outperform a domain-specific biomedical model on structured query generation for pharmaceutical manufacturing data. Although fully local, GxP-aligned NLQ systems are feasible on consumer hardware, current performance levels still require human oversight and downstream validation for regulated use.

Rajan Bastakoti, Sagar Bhetwal, Nirajan Acharya et al.

Retrieval-Augmented Generation (RAG) has become foundational for grounding large language models in domain-specific corpora, yet conventional vector-based RAG systems are fundamentally limited in their ability to capture the structured, multi-entity relationships that underpin financial market analysis. This paper presents a comprehensive comparative study of a novel two-hop Graph-RAG architecture versus a standard vector-only baseline for cross-entity financial sentiment analysis. Our system constructs a sentiment-weighted knowledge graph of 59 equity entities from 255 news articles covering 10 major technology stocks, then augments dense retrieval with intensity-filtered graph traversal over INFLUENCES edges to surface relational evidence inaccessible to vector search alone. We evaluate both architectures on 100 grounded queries (30 Direct, 70 Relational) using semantic similarity, entity recall, RAGAS metrics, latency benchmarks, and ablation studies. Graph-RAG achieves a statistically significant improvement in entity recall (+6.4%, p < 0.001, Wilcoxon signed-rank) and delivers substantially more relevant answers for complex multi-entity queries (+11.7% Answer Relevancy), with gains concentrating in relational question types (+16.1%). Critically, these improvements come at no measurable cost to answer quality (delta = +0.001 semantic similarity, Cohen's d = 0.078), with a modest 22.6% increase in mean latency offset by an 80% reduction in latency variance. An ablation study on the graph traversal intensity threshold reveals an inverted-U relationship with answer quality, identifying tau = 0.5 as optimal over the production default of tau = 0.7. These findings characterize a precision-for-coverage trade-off inherent to graph-augmented retrieval and provide actionable architectural guidance for practitioners building RAG systems for multi-entity financial analysis.