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:
• BMIC Process WG: cover the necessary process, equipment, and parameter entities for capturing plans for the cell culture production process in the first stage. In the second stage, the ontology shall be able to capture the executions (i.e., actual occurrences) of those plans.
• BMIC Quality WG: cover the necessary measurement process, equipment, and method entities for capturing plans and execution for monitoring and control of the cell culture production process in the first stage. In the second stage, another ontology for describing statistical data shall be developed or adapted from an existing ontology.
• BMIC Materials WG: cover entities for capturing material properties of media and its components used as a raw material for the cell culture process.
COMING SOON
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Open Applications Group, Inc.
