Biopharmaceutical supply chains have evolved beyond single-source manufacturing to a complex network of collaborations and partnerships between sponsors and contract organizations. However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. This paper explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future.
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This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.
The purpose of the MES of the future manifesto is a call to action from the biomanufacturing industry to vendors of MES solutions. The manifesto articulates: the gap between the current generation of MES solutions and the needs of the biomanufacturing industry and a realistic and achievable vision for the MES of the future that will meet the needs of the biomanufacturing plants of the future. It is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions that will outline roadmaps for future development.
What does the concept of ‘digital plant’ mean in biopharmaceutical manufacturing? How can it be defined, measured and transformed? What is needed to move up the maturity curve. All are questions that a business needs to answer to establish a practical strategy and realize the opportunities that digital offers.
The biomanufacturing Digital Plant Maturity Model (DPMM) describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. The maturity assessment tool can be used alongside the model. Using the characteristics provided for each dimension of the model, an assessment can be made of a plant or a network of plants against the five digital maturity levels against eight dimensions. The maturity model and provides the language and mechanism for having the right conversations with the right stakeholders and the Assessment Tool ensures a neutral assessment of the current state, and facilitates agreement on the future state.