Why is this important?
Chemical development has been supported by the ISA 88 standard for decades. A lot has changed in that time, and a more flexible, comprehensive representation of process data is needed. A contemporary ontology provides the data representation that is needed to facilitate data integration, data exchange and data insights.
The Pistoia Alliance has completed Phase 1 / Proof of Concept to build a pharmaceutical CMC process ontology based on the ISA88/95 framework.
The aim is to standardize laboratory and plant production process recipes to establish standardized definitions, facilitate digital technology transfers and integration with execution systems to capture structured process data for material lot genealogy tracking, streamline technology transfers, and advanced process analytics, and thereby enhance efficiency and transparency throughout the pharmaceutical production lifecycle.
For this project’s initial phase, we worked on three use cases: Process Definition, Process Monitoring, and Comparative Analysis. The focus was on the processes for making the APIs and the drug products, initially focusing on biologics and synthetics.
In this video, we show how we have imported the developed core CMC process ontology as well as two controlled vocabularies for referring to the different parameter measurements as well as the different recipe steps that make up a manufacturing process to create a knowledge graph to answer our competency and business questions.
Hear directly from our Project Manager, and ontology expert, Birthe Nielsen and Cameron Gibs from Crown Point, about the “CMC Process Validation Walkthrough” below…
What will the project achieve?
The scope and key deliverables of this work will include:
- CMC laboratory & manufacturing scale API & Pharmaceutical Product processes
- Biologics & Synthetics with an initial focus on protein and chemical processes
- Develop domain lexicon and domain taxonomy to accomplish seamless convergence of the protein and chemical processes
- An advanced semantic architectural design for a Process Ontology, featuring seamless integration with the established Product (IDMP-O), Analytical (AFO), and Unit of Measure (QUDT) ontologies
- A taxonomy and controlled vocabulary based on the ISA88/95 framework for Process/Stage /Operation/Action, Process Parameters, Process Performance Indicators, and their definitions
How will the project do this?
Initially, we will work to cover the following use cases:
- Standardize and digitize laboratory production process (stage) definitions, enabling structured process data capture.
- Establish digital API & Pharmaceutical Product process definitions for automated CMC dossier authoring
- Enable digital Process Technology Transfer from laboratory to plant (scale up) and between plants
- Enable advanced process analytics (process performance) across laboratory and process batches (across scale)
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