Open-sourced Biopharmaceutical Manufacturing Ontology

NIIMBL contributed collaboratively developed ontologies produced by its Big Data Program to an open-source platform (OAGi), which aims to accelerate development and adoption of data-driven innovation and standards within biopharmaceutical manufacturing.
Categories
Drug substance
Data

Industry Need

Poor data interoperability in Product Development and Manufacturing owing to different computerized design, analysis, and manufacturing software and hardware systems among functions within and between different companies.

Approach

Use Opensource communally developed and implemented Ontologies to provide an integrating environment for information repositories to enable semantic annotation, search/retrieval, and knowledge representation between systems throughout the design to manufacture lifecycle, within and between companies.

Impacts

Reduce Operational and Delay Costs from Data Management, Discounted Ontology Development Cost

Savings of 12 FTE-mo per product for Operational Costs; Examples: Data search, retrieval, analysis, and documentation from external repositories' (ex. CMO, Suppliers, Regulators, Business Partner) for Process Design, Technology Transfer, Manufacturing, Quality Control, Regulatory Submissions, Inspections, and Annual Reports

Savings from NIIMBL leveraged contract for OAGi/IOF Opensource Ontology Development specialist

Outputs/Deliverables

  • Ontology Data Files (2024 and beyond)

Additional Project Information (Members Only)

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

AstraZeneca

AstraZeneca

Boehringer Ingelheim

Boehringer Ingelheim

Bristol-Myers Squibb

Bristol-Myers Squibb

Cytiva

Cytiva

EMD Millipore Corporation

EMD Millipore Corporation

Eli Lilly and Company

Eli Lilly and Company

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Genentech, Inc.

Genentech, Inc.

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

Pfizer, Inc.

Pfizer, Inc.

Sanofi

Sanofi

Sartorius Stedim

Sartorius Stedim