Pharma on STEM to STEAM

Artificial Intelligence

Mon, 01 Jan 0001 00:00:00 +0000

There has been a lot of hype around AI and pharma - how it can reduce costs and remove a lot of manual labor that for sometime was always seen as necessary human activities, that is writing. But now with large language models, AI can really start eroding away at those manual human tasks and launch us into the Industry 5.0 mentality of workers with AI assistance to do their jobs.

Control Strategies

Sun, 08 Sep 2024 11:07:23 +0000

Introduction to Control Strategy, Design Space, and Knowledge Space in Manufacturing#

In modern manufacturing, especially in regulated industries like pharmaceuticals, ensuring product quality is paramount. The International Conference on Harmonisation (ICH) introduced the concept of Quality by Design (QbD) to promote a more robust and scientific approach to product and process development. Central to QbD are the concepts of Control Strategy, Design Space, and Knowledge Space, which together ensure that manufacturing processes consistently produce high-quality products. Here’s a breakdown of these key elements:

Analytical Chemist

Mon, 01 Jan 0001 00:00:00 +0000

An analytical chemist ensures data quality, traceability, and measurement accuracy across scientific and engineering projects. This persona is a natural bridge between laboratory science and creative innovation.

In the STEAM knowledge graph, the analytical chemist sits at the intersection of Science (Chemistry) and Arts (Pharma, Control Strategy), generating the empirical data that flows into Mathematics (Predictive Modeling) and Technology (Big Data analytics).

Paper on Glass: Digital Process Data Capture with S88/S95 Ontology Alignment

Mon, 01 Jan 0001 00:00:00 +0000

Abstract#

The “paper on glass” paradigm represents a transformative approach to industrial process documentation, where traditional paper-based records are digitally replicated while maintaining familiar workflows. This paper explores how such systems can be enhanced through alignment with established manufacturing ontologies, specifically ISA-88 (S88) batch control and ISA-95 (S95) enterprise-control integration standards, creating a unified framework for recipe management and process data capture.

Introduction#

Manufacturing industries have long relied on paper-based documentation for recipe management, batch records, and process data collection. The “paper on glass” concept digitizes these familiar interfaces while preserving the cognitive patterns operators have developed over decades. However, true digital transformation requires more than visual replication—it demands semantic alignment with standardized ontologies that enable interoperability, data consistency, and automated processing.

Pharma Product Developer

Mon, 01 Jan 0001 00:00:00 +0000

A pharma product developer coordinates research, formulation, manufacturing, and regulatory strategy to bring new therapies to market. This persona is a key connector between science, engineering, design, and human-centered outcomes.

In the STEAM knowledge graph, the pharma product developer traverses all five domains: grounded in Science (chemistry, biology), structured by Arts (knowledge management, QbD), validated by Mathematics (predictive modeling), implemented in Engineering (manufacturing), and enabled by Technology (digital tools, Industry 4.0).

Pharma on STEM to STEAM

Artificial Intelligence

Control Strategies

Introduction to Control Strategy, Design Space, and Knowledge Space in Manufacturing#

Analytical Chemist

Knowledge Graph Connections

Paper on Glass: Digital Process Data Capture with S88/S95 Ontology Alignment

Abstract#

Introduction#

Pharma Product Developer