CMC Process Ontology
Project Charter
The Pistoia Alliance has developed an advanced semantic architecture for a Pharmaceutical CMC Process Ontology. The objective is to create a domain lexicon and taxonomy that extend the ISA‑88 framework, enabling standardized laboratory and plant production process recipes.
The CMC Process Ontology is explicitly focused on process and process development, while providing defined integration points to related domains such as analytics, materials, equipment, and quality.
The CMC Process Ontology
The standardization achieved via the CMC Process Ontology establishes consistent definitions for processes and their development, supports digital technology transfer, and enables integration with execution systems to capture structured process data. As a result, the CMC Process Ontology improves material lot genealogy tracking, streamlines technology transfer, and enables advanced process analytics, enhancing efficiency and transparency across the pharmaceutical production lifecycle.
During the initial project phase (2024), the team delivered significant gains in addressing inefficiencies in technology transfer and data integration across stages and scales, as well as integration across production systems. We showed how an ontology-driven approach can improve efficiency and transparency throughout the pharmaceutical production lifecycle. In the second phase (2025), we expanded the ontology scope to facilitate optimal process scale-up. The ontology now captures and defines process steps at the development stage of chemical, monoclonal antibody (mAb), and CAR-T manufacturing, including key process parameters in the P-S-O-A (process, stage, operation, action) model. Phase 3 (2026) focuses on building out integration among the CMC Process, Equipment, Material, Analytical (measurement and quality attribute), and IDMP ontologies to ensure interoperability across the value chain, and on creating a data model for practical implementation and real-world enablement.
The Pistoia Alliance’s CMC Process Ontology imports the IOF Biopharma Ontologies to support aspects of biopharmaceutical CMC, and is aligned with the Basic Formal Ontology to facilitate broad interoperability.
Access to the CMC Process Ontology:
The Pharmaceutical CMC Process Ontology establishes the core process framework, aligned to ISA-88 principles, and provides a shared semantic foundation for representing process structure, recipes, execution context, parameters, sampling, and key process linkages. It has been tested and refined against real laboratory and process scenarios, and is structurally compatible with leading complementary ontologies, including through collaboration with the Allotrope Foundation and the IOF.
The CMC Process Ontology Version 1.1.0 is available for Pistoia Alliance members in the Release Repo under a Pistoia Alliance members-only license.
A public version is intended to be released in November 2026 via a public GitHub.
Development is ongoing to expand ontology coverage and facilitate its practical application. Funding members of this project have access to the latest development version via a private GitHub repository.
If you are interested in accessing the CMC Process Ontology Version 1.1.0 and providing feedback, please contact birthe.nielsen@pistoiaalliance.org.
Get involved in Phase 3
Talk to Birthe Nielsen to learn more and get involved in Phase 3 of this project
Contact Birthe
