A 1.5-day Workshop and Ontology Demonstration
In Person – Boston & Cambridge (MA) – By Invitation
Hosts
The Pistoia Alliance is building the advanced semantic architectural design for a Pharmaceutical CMC Process Ontology.The initial MVP involves the domain lexicon and taxonomy building to extend the ISA88 framework 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, streamlined technology transfers, and advanced process analytics, thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle.
The initial phase of the project delivered a series of critical improvements to inefficient technology transfer and data integration between stages and scales, as well as integrating data across production systems. We showed how an ontology can improve efficiency and transparency throughout the pharmaceutical production lifecycle.
For the second phase of the project (2025), we are extending the scope to a comprehensive CMC process ontology for chemical, mAb, CAR-T manufacturing, capturing and defining all process steps, key process parameters and P-S-O-A (process, stage, operation, action) designations to ensure optimal process scale-up and optimization. This 1.5-day workshop will demo the outcome from this phase and discuss critical next steps for the development.
Collaborative development will drive success, and if industry-wide data standards and approaches to data management are to be agreed upon and implemented successfully, organizations need to collaborate.
This workshop aims to widen the project team to propagate the pharmaceutical CMC process ontology project to become an integral part of the system infrastructure in all pharmaceutical and manufacturing facilities. We now also welcome vendor support to develop implementation guidelines for the application of the Process Ontology to process recipes within electronic Laboratory Notebooks (eLN) and Manufacturing Execution Systems (MES) and the creation of ePTDs.
Introducing and adopting shared standards improves the efficiency and effectiveness of R&D. It improves quality and reduces the cost and time burden on scientists and their organizations.
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 phase.
For further information, please email birthe.nielsen@pistoiaalliance.org.
Learn more about the CMC Ontology Project here.