The Pistoia Alliance’s CMC Process Ontology
How to Structure Manufacturing Process Data
Tổng quan chương trình
- Project background and collaborative framework
- Ontology Structure and ISA 88 framework alignment
- Use cases and technical implementation
- Integration with vendor systems and data mapping
Birthe Nielsen from the Pistoia Alliance presents their ongoing CMC Process Ontology project, details its collaborative development, alignment with industry standards, and integration with vendor systems like METTLER TOLEDO. We discuss the Pistoia Alliance's mission to lower innovation barriers through pre-competitive collaboration, describing the CMC Process Ontology's development over two years with input from multiple pharmaceutical companies, technical vendors, and working groups. Key use cases include process definition, monitoring, tech transfer, and comparative analysis, with the ontology supporting structured data aggregation, standardized parameter tracking, and integration with other ontologies and metadata standards for enhanced data utility.
About the Presenter
Birthe Vejby Nielsen, Ph.D.
Consultant, Pistoia Alliance
Birthe is curious individual with a great passion for science, knowledge translation & transfer, and enabling collaborative innovation across companies and industry sectors. She completed a Ph.D. in Pharmaceutical Sciences and has more than a decade of experience within academia with a solid technical background in Analytical Sciences. Based in London, she works as an independent consultant in Life Science and Healthcare R&D.
