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.

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

Value Statement/Outcomes

The move to standardized ontologies eliminates the need for redundant, manual data mapping, capturing an additional $240K in value per product by reallocating 24 months of FTE labor toward high-value innovation instead of administrative data cleanup. Most critically, this standardized framework de-risks our commercial timeline; by mitigating the 10% chance that a critical-path data error could stall a launch, this protects against potential lost sales—a safeguard valued at $300K per product—ensuring that life-saving therapies reach patients without avoidable digital bottlenecks.