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NIIMBL and Open Applications Group (OAGi) partner to develop open-source biopharmaceutical manufacturing ontologies
Friday, June 21, 2024

NEWARK, Del. and ATLANTA, June 13, 2024 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has contributed biopharmaceutical manufacturing ontologies to The Open Applications Group (OAGi) for further development as an open-source project. Shifting NIIMBL's ontology work to an open-source process will encourage broader involvement and adoption of common processes, increasing the overall benefit to the biopharmaceutical industry.

Ontologies are semantic information models tailored for domain experts with clear, formal, and natural language definitions and labels. It represents a data domain through entities, their relations to each other, and literal values.

"These biopharma-specific ontologies will improve interoperability and optimize productivity by allowing data engineers to access, analyze, and share data about their manufacturing processes," said Roger Hart, NIIMBL Senior Fellow and Big Data Project Lead. "The open-source platform will ensure industry access to the ontologies and allow for continued development and modifications. It will also provide a centralized repository to collect and curate ontologies which are currently privately created and used by small groups within the community."

OAGi plans to establish a Biopharmaceutical Manufacturing Industry Council (BMIC), which will identify working groups to develop ontologies. The BMIC will join OAGi's ongoing work in industrial ontologies through its Industrial Ontologies Foundry (IOF).

NIIMBL has contributed ontologies produced by its Big Data Program, which aims to accelerate the development and adoption of data-driven innovation and standards to increase the speed and resilience of biopharmaceutical manufacturing. The ontologies were developed as part of a successful proof-of-concept project for a set of biopharmaceutical manufacturing use cases.

Serm Kulvatunyou, NIST Researcher, co-leader of the NIIMBL Standardization and Contextualization project, and co-founder of IOF, states "The NIIMBL ontology is based on the IOF Core ontology, which was comprehensively defined for the manufacturing industry based on the well-founded Basic Formal Ontology, as well as the ISA-88 and ISA-95 standards. As an extension of such well-founded ontologies and standards, NIIMBL ontology positions itself for broader industry adoption. It is with great excitement that NIIMBL has contributed this ontology and is interested in broadening its applicability to other manufacturing industry sectors. IOF will bring additional resources, particularly on ontology design, rigor, broad domain expertise, and development infrastructure, to further strengthen the ontology."

The NIIMBL-contributed ontologies are built upon and aligned with leading upper ontologies, including IOF Core and Basic Formal Ontology (BFO). These ontologies are complimentary to other IOF ontologies under development, which are all cross-industry presently.

"The NIIMBL-contributed ontologies are the first step in a journey to radically improve interoperability in the biopharmaceutical manufacturing industry," said Jim Wilson, OAGi's CEO. "The combination of the NIIMBL ontology contribution, biopharmaceutical manufacturing experts, IOF experts, and IOF ontologies is a recipe for success not just for biopharmaceutical manufacturing, but for the dozens of other industries using OAGi standards."

To ensure sufficient resources for ongoing work, OAGi and NIIMBL defined a sponsorship model whereby companies, institutions, and government agencies can contribute funds to hire experts and enhance infrastructure as required to meet project timelines. This sponsorship model can be applied to projects serving other industries as well.

NIIMBL and OAGi/IOF are looking for additional experts to contribute to the continued development of these ontologies. To join OAGi / IOF or to learn more, go to


The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA(®), a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.

NIIMBL contact:

News Media
Daniel Maiese
Communications Manager
+1 302-831-3824

About OAGi and IOF

OAGi is a non-profit standards organization with the mission to improve data interoperability within and among enterprises by developing data standards, ontologies, and other resources. The IOF is an OAGi division.

OAGi contact:

Michelle Banks
+1 404-402-1962

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SOURCE National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

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