Driven by scientific and technical innovations, an explosion in available data, and the need to get faster and more effective, the migration of biopharmaceutical manufacturing to a digitally mature environment is a high priority. Standards and best practices are emerging, but few organizations effectively leverage these tools. At their core is the data required to drive improvement.
Key challenges are that data is scattered across multiple systems, it exists in various formats, and it is difficult to assemble in the proper context for evaluation, reporting, and decision support.
A better approach to data management is needed to upgrade biotech and pharma operations to the conceptual standards of Pharma 4.0.
This paper is a critical first step toward better data management and establishing a standard ontology for biomanufacturing. It defines the critical concepts for describing and capturing a manufacturing process independent of the systems and equipment used.
The BioPhorum Team carried out an initial proof-of-concept implementation of an ontology-enabled analysis at the North Carolina State Golden LEAF Biomanufacturing Training and Education Center (BTEC). As part of the proof-of-concept, BTEC underwent elements of a digital transformation to enable better data measurement and capture to ensure the ontology implementation would be successful. BTEC then implemented BioPhorum’s standardized ontology that enabled the synchronization of online and lab data measurements to calibrate optical density probes across five bioreactors.
Using this ontology-based software reduced the duration of the calibration workflow from 4 hours to 30 minutes!