A major milestone for digital pharmaceutical manufacturing, version 1.0 delivers a standardized, machine-readable framework for CMC processes and is now available to Pistoia Alliance members.
The Pistoia Alliance today announced the release of Version 1.0 of the Pharmaceutical CMC Process Ontology, a major milestone in the effort to create a standardized, machine-readable representation of pharmaceutical Chemistry, Manufacturing and Controls (CMC) processes.
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. Version 1.0 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.
The release marks the point at which the ontology is mature enough to be made available beyond the project’s funding members, with automation in place to manage updates, provide syntactic validation, and capture community feedback. The ontology has also been tested and refined against real laboratory and process scenarios and is structurally compatible with leading complementary ontologies.
“Version 1.0 is the outcome of careful ontology development and maturation and is now being made available to the broader Pistoia Alliance membership for exploration and implementation,” shared a member of the project’s Steering Committee. “It is structural compatible with complementary ontologies, a prerequisite for its flexible deployment in a foundational role, accommodating both early science and discovery use cases at laboratory scale, and the increasingly formal controlled specifications required as processes progress into manufacture. We expect this to help adopting organizations identify common lineage across process development and manufacturing.”
Birthe Nielsen, Project Manager for the CMC Process Ontology at the Pistoia Alliance, added: “Version 1.0 has been tested and refined against real laboratory and process scenarios. That gives us confidence the ontology is not only theoretically sound but practical and usable for describing real-world processes, a credible foundation for broader adoption and future expansion.”
Development of the ontology is ongoing, with planned expansion of coverage including process execution context. Funding members of the project have access to the latest development version via a private GitHub repository.
To learn more about the project behind the CMC Process Ontology, visit the project webpage.
To request access to Version 1.0 and provide feedback, contact Birthe Nielsen.