The Pistoia Alliance is developing a semantic framework for a Pharmaceutical CMC Process Ontology. The work includes building a shared domain lexicon, taxonomy, ontology, and data model to extend the ISA-88 framework and support the standardization of laboratory and plant production process recipes.
To date, the project has established a strong foundation for improving technology transfer and data integration across pharmaceutical development, manufacturing scales, and systems. The work has focused primarily on defining processes, demonstrating how an ontology-based approach can improve efficiency, transparency, and consistency across the pharmaceutical production lifecycle. In 2025, the scope expanded into a comprehensive CMC process ontology covering chemical, biologics, monoclonal antibody, and CAR-T manufacturing, including process steps, key process parameters, and process-stage-operation-action designations to support scale-up and optimization. Version 1.0 of the ontology was released in May 2026, marking an important milestone for the project and providing a foundation for broader implementation.
Phase 3 (2026) is now underway and broadens the ontology to include process-execution hooks, contextual information, materials, and equipment. This work is being translated into a practical data model that can support implementation across real-world systems and workflows. As a result, the next priority is to help organizations understand how the ontology and data model can be applied in practice.
This two-day workshop will focus on implementation: how the Pharmaceutical CMC Process Ontology and associated data model can be used to structure, manage, and exchange process recipe information across laboratory and manufacturing environments. Through practical demonstrations and discussion, participants will explore how the ontology can be applied, how to take the first steps towards implementation, and how to make the ontology practical, interoperable, and useful across real-world settings.
We wish to expand the project team and position the pharmaceutical CMC process ontology as an integral part of digital and operational infrastructure across all pharmaceutical and manufacturing facilities. Collaborative development will be essential to success. For industry-wide data standards and data management approaches to be agreed, adopted, and implemented effectively, organizations need to work together.
We welcome input from process experts, digital and data teams, manufacturing, quality, automation, technology providers, and vendors. In particular vendor support to develop implementation guidelines for the application of the CMC Process Ontology to process recipes within electronic Laboratory Notebooks (eLN) and Manufacturing Execution Systems (MES) and the creation of ePTDs.
We are keen to welcome new contributors to the project to continue discussing common barriers to successful process recipe management and work together to extend the ontology and use cases beyond the current phases.
The workshop is hosted by ZS and AbbVie. Joining instructions will follow.
To be considered for a space in the workshop, please complete the registration form. If you have any questions, please email birthe.nielsen@pistoiaalliance.org.