Industrial need for standardizing and digitalizing biopharmaceutical manufacturing processes; by way of enhancing data interoperability, improve process analysis capabilities, and ultimately drive innovation in biopharmaceutical production.
The first-year use case scope is to enable biopharmaceutical engineers to store, query, and analyze material, process, and product quality data to determine the correlation between media composition, process performance indicators, and product quality attributes. Based on the use case, three working groups (WGs) are envisioned during the first year, including the BMIC Process WG, BMIC Quality WG, and BMIC Materials WG. BMIC stands for Biopharmaceutical Manufacturing Industry Council (BMIC). The target scopes of these WGs are as follows:
By implementing the BMIC ontology to bridge data gaps between process, quality, and materials, the project mitigates a $300,000 risk per product associated with a 10% probability of launch-critical data delays. While the technical integration requires 36 FTE-months of labor valued at $360,000, the net internal cost is slashed by over 55% through a $200,000 NIIMBL-leveraged funding credit. Ultimately, this investment delivers a $140,000 net economic gain per product by converting standardized interoperability into protected market revenue.
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Open Applications Group, Inc.
