NIIMBL Big Data Program Biopharmaceutical Manufacturing Ontology

The aim of the NIIMBL Big Data Program Biopharmaceutical Manufacturing Ontology is to collaboratively develop an industrially relevant shared ontology for three-unit operations (bioreactor, harvest, and ProA capture chromatography) in biomanufacturing.
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 companies.

Approach

Use 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 companies.

Impacts

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

Savings of 24 FTE-mo per product for Operational Costs; Examples: Data search, retrieval, analysis, and documentation for Process Design, Technology Transfer, Manufacturing, Quality Control, Regulatory Submissions, Inspections, and Annual Reports

Savings of 30 days for Delay (arise from interoperability problems that delay the introduction of a new product); Examples: Manual/Slow processes to ensure data traceability, verify data quality, respond to regulatory questions

Savings from NIIMBL leveraged contract for Ontology Development specialist

Outputs/Deliverables

  • Ontology Data Files (done)
  • Hart (2023) BPI Presentation – Opensource Biomanufacturing Ontology
  • Kulvatunyou (2023) Presentation
  • Webinar (2023)

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