The Pistoia Alliance, a nonprofit alliance that advocates for greater collaboration in life sciences R&D, launched the next phase of its Chemistry, Manufacturing and Controls (CMC) Process Ontology project on Thursday. The project, which aims to develop a pharmaceutical CMC process ontology based on the ISA-88/95 framework, is supported by Eli Lilly, Amgen, Merck & Co., AstraZeneca, GSK, Johnson & Johnson and more.
Credit: Pistoia Alliance
The CMC Process Ontology creates a common language for describing the development and manufacturing of drugs. Using a consistent format allows data from electronic lab notebooks (ELNs), laboratory information management systems (LIMS) and manufacturing execution systems to be shared across teams and platforms.
The CMC Process Ontology project aims 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,” according to the project website.
The new phase aims to solve the issue of inconsistent, siloed experimental and process data in the life sciences. A survey conducted by the alliance showed that 49% of labs cite data standards and ontologies as a major gap preventing data from being FAIR: findable, accessible, interoperable and reusable.
Data source: 2025 The Evolution of Labs report by Pistoia Alliance
Phase 3 of the project will build on existing coverage for small-molecule, biologic and synthetic processes, testing interoperability with vendor systems and releasing open resources. The alliance is inviting pharmaceutical companies, technology vendors and research organizations to be project sponsors and contributors.
“Through this next phase of the CMC Process Ontology, we will deliver practical standards that make life sciences data AI-ready and interoperable from the lab through to manufacturing,” said Becky Upton, president of the Pistoia Alliance.
The alliance has completed Phase 1 (a proof of concept) and Phase 2, which focused on extending the scope of the CMC process ontology across chemical, monoclonal antibody (mAb) and CAR-T manufacturing. Phase 2 transformed the framework into a production-ready resource, featuring a standardized vocabulary that enables recipes to be understood across various systems.
Filed Under: Data science
