Industry-defined opportunities for advancing big data capabilities in biopharmaceutical manufacturing.

Biopharmaceuticals are the originating products of biotechnology, an area of increased focus for strategic U.S. leadership. The discovery, development, and manufacturing of biopharmaceuticals create large amounts of data, which is then managed and preserved for business and regulatory purposes. In accordance with the resource-based view management framework, this data is a resource which, when combined with the right capabilities, is foundational to building a company's competitive market advantage. Big Data Capabilities to acquire, analyze, curate, store, and use data for targeted purposes across the entire biopharmaceutical manufacturing lifecycle are key to realizing business value from big data collections. This paper describes these capabilities in relation to recent advances in biopharmaceutical manufacturing and the benefits these capabilities can help realize. We argue that developing shared capabilities benefits both individual businesses, who can adopt and adapt them to establish their own strategy and competitive advantage, as well as the entire industry, which advances biopharmaceutical science through shared knowledge and collaboration. This paper was derived from extensive material collected from biopharmaceutical manufacturing industry subject matter experts gathered by the Big Data Program of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).