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MAY-JUN 2017

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Digital Plant Maturity Model Digital stages for biopharmaceutical production plants By Eric Anttonen, Harmik Begi, Michael Dubs, Ian Helliwell, and Jane Selva A lthough it is a hot topic among biologics manufacturing companies, there is no consensus on what actually constitutes a "digital plant." Is it a paperless plant or a fully automated facility? What makes it the factory of the future? How does this relate to Industry 4.0 and the Industrial Internet of Things? Different companies have different levels of aspiration, and so individual definitions of a digital plant vary in process and technology sophistication— all adding to the complexity of the picture. Addressing this lack of clarity by developing a single model that covers the continuum of digital maturity stages for a biopharmaceuti- cal production plant was the task of the Digital Plant Maturity Model (DPMM) team when they embarked on the project in 2016. The model describes the stages of maturity from simple paper-based plants to the fully automated and integrated "adaptive plant" of the future. The team that developed the model is a col- laboration comprising 20 industry experts from 11 major biopharmaceutical compa - nies. This multifaceted team has expertise in manufacturing, information technology (IT), automation, and analytics. Their strength lies in understanding not only the industry and its technology, but also the evolving biologics market and the innovations that will enable it. A description of the DPMM and how it was constructed is laid out in the white paper, "The development of a Digital Plant Maturity Model to aid transformation in biopharmaceutical manufacturing," which is now available on the BioPhorum website (www.biophorum.com/ category/accelerate/white-papers). FAST FORWARD l What constitutes a digital plant, and how does this relate to Industry 4.0 and the Industrial Internet of Things? l The Digital Plant Maturity Model (DPMM) from the BioPh orum Operations Group defines the stages of maturity from paper-based plants to fully automated and integrated "adaptive plants" of the future. l The DPMM is not specific to the biopharmaceutical industry; it is equally applicable to small molecule manufacturing, medical devices, and other areas. 32 INTECH MAY/JUNE 2017 WWW.ISA.ORG

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