Digital Plant Maturity Model
Digital stages for biopharmaceutical production plants
By Eric Anttonen, Harmik Begi, Michael Dubs, Ian Helliwell, and Jane Selva
Although 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 biopharmaceutical 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 collaboration comprising 20 industry experts from 11 major biopharmaceutical companies. 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).
The DPMM covers not only what is possible today, but also defines an advanced-level adaptive plant that is currently beyond the capabilities of manufacturing and IT technologies. The content of the model was developed with the BioPhorum Technology Roadmap (due to be published midyear), as well as with input from some key IT vendors and initiatives such as Industry 4.0. The white paper introduces the DPMM and its uses as both a tool for companies to plot their digital journeys and to identify the common challenges for companies wishing to increase their maturity level.
The model has five levels that characterize the different stages of digital maturity of the plant and its relationship with the wider value chain. These are described at a high level in figure 1.
There are two categories of dimensions in the model:
Business capability dimensions: This category includes the primary business capabilities required to design, build, operate, and maintain the digital plant and its role in the end-to-end enterprise value chain. These capabilities are:
- manufacturing automation and process execution
- lab execution and quality management
- manufacturing support
- production planning and supply chain
Enabling capability dimensions: This category includes the people, processes, technology, and information capabilities required to enable the above business capabilities. These capabilities are:
- people and culture
- business insights and analytics
- end-to-end value chain integration
- systems interoperability and governance
- IT security and operations
The model itself comprises a comprehensive, detailed reference of the characteristics of each dimension at each level of maturity. A simple plant assessment tool has also been developed to allow people with no prior exposure to the model to carry out plant assessments with consistency. This consistency of use facilitates internal benchmarking and gap analysis within the networks of plants typical of large biopharmaceutical manufacturers. The tool is a semi-automated spreadsheet. The summary page is shown in figure 2 and illustrates a typical plant assessment.
A trial of the DPMM and the simple plant assessment tool is being carried out within the collaborating biopharmaceutical companies, where the emerging picture shows an industry with a long way to go to reach higher levels of digital maturity. The model has also been used to identify key challenge areas for these companies, which are now collaborating on several initiatives to help the industry move the needle on digital maturity.
The collaborating companies are also starting to see other uses for the model: It provides a common language for technical/business discussions; it can be used to define strategy and set aspiration; and the rich detail behind the model can be used to do gap analysis and aid in transformation planning. One company is even using the model to help shape future technical skills profiles to aid career progression. Additionally, it can unite the industry and its technology vendors to ensure the right IT solutions and services are developed to assist the industry in its drive for higher digital maturity.
A significant observation is that the DPMM is not specific to the biopharmaceutical industry. It is equally applicable to small molecule manufacturing, medical devices, and other areas beyond pharma. In short, the industry now has a tool in which it can set ambitions and plot and measure its transformation journey. Importantly, it represents a uniting of minds and industry experts. They are catalyzing the call to action within the broader ecosystem-IT developers and vendors, industry suppliers, thought leaders, and external experts-to align and focus the development of capabilities, technologies, standards, and know-how-ultimately to the benefit of patients and to the wider healthcare ecosystem.
Figure 1. DPMM: Definitions of levels
Figure 2. Simple plant assessment tool