The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the Open Applications Group (OAGi) in the US have jointly unveiled a pioneering set of ontologies designed to enhance data interoperability and analytics capabilities across the biopharmaceutical industry.

Developed through OAGi’s Industrial Ontologies Foundry (IOF) initiative, the new ontologies represent a collaborative effort involving domain experts, standards developers and leading industry organizations. They provide a semantic foundation for consistent data exchange, integration and interpretation.

Covering core biomanufacturing concepts, including process parameters, equipment, quality attributes, various types of recipes and their components, processing steps and materials, the ontologies are designed to serve as a common reference framework for systems integration, data analytics, regulatory submissions and digital transformation initiatives across the biopharmaceutical manufacturing value chain.

"Ontologies give us a shared language to structure and contextualise manufacturing data. With this release, we're one step closer to seamless interoperability across our systems, suppliers and regulators. With this release, we see growing progress toward cross-consortia collaboration to create an interoperable ontology to serve the biopharmaceutical manufacturing industry," said Roger Hart, NIIMBL Senior Fellow and Big Data Program Lead.

The initiative has received strong backing from industry leaders, who view the ontologies as a key enabler for data-driven innovation in biomanufacturing.

"This ontology will be beneficial to the development of biopharmaceuticals because it will facilitate communication amongst those with diverse backgrounds. The human-readable aspects of it provide a shared language and reference point for effective communication between organizations.  The machine-readable aspects will enable automated organization and visualization of data from disparate sources, a task that is frequently time consuming and performed manually," said Jan Kemper, Associate Principal Automation Engineer at AstraZeneca.

Markus Hartmann, Global Product Lead for Data Semantics at MilliporeSigma, added, “This unification of data from diverse sources not only ensures seamless interoperability but also accelerates insights that improve product quality, yield, and time to market.”  

The ontologies are now publicly available under an MIT-style license and are expected to be adopted by technology vendors, regulatory bodies and biomanufacturing organisations seeking to modernize their data infrastructure and promote digital maturity.