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Digital Technology Roadmap

8 July 2022
Information Technology
Technology Strategy
Digital Technology Roadmap
8.24 MB
941 downloads

The Digital Plant Maturity Model (DPMM)1 describes one characteristic of a Level 5: Adaptive Plant as “In-line, real-time, continuous, closed-loop, process verification and control with automated realtime quality release”. This is the pinnacle of ‘Industry 4.0’, a term coined around 2011 to outline the advantages that a wide array of digital technologies running in concert can bring to manufacturing and critical facilities. For most pharmaceutical manufacturers, the strategic advancements these technologies can deliver have not been realized.

While there are digital technologies in place delivering some value, they are not enterprise wide, not fully integrated, they do not leverage the full extent of the available infrastructure, and they are not working together. There is no single reason for the industry to lag in adopting these technologies. In such a highly regulated industry, there is inherent complexity and an unprecedented pace of change. However, the COVID-19 pandemic has shown that the industry can overcome real and perceived barriers for the common good. The pandemic demonstrated that digital technologies offer great value and can move the needle on all five drivers identified in the BioPhorum Technology Roadmap Vision 2.0², challenging the industry’s existing ways of investment, technology development and technology adoption with thresholds and timelines falling outside the norm. Strategic decision makers need to be informed and well supported in developing a value proposition for digital transformation to ensure that the investments they make are transformational.

Continuous, closed-loop control is not the goal for everyone. In this paper, the Digital Technology Roadmap working group 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. Part 2, to be published later, will provide practical guidance, tools and evidence to support an approach to digital transformation which focuses on what an organization needs to deliver, but also its need not to constrain itself for the future, and to look beyond the walls of the facility and use technology to deliver data accessibility with all the challenges that data sharing brings about. Beyond the facility, and organizations already embarked upon digital programs, there is an adoption curve that moves the industry toward a critical mass of transformational change which needs to be achieved for organizations to realize the full promise of Industry 4.0.

Transformational change is not a program but a mindset that enables organizations to remove siloed working, effect organizational change, enable an adaptive and optimized workforce, and in some cases remove the need for human operations in some facilities with remote support being utilized by exception. Biopharmaceutical manufacturing companies that are willing to undertake this digital journey in the face of the acknowledged regulatory challenges will see that the benefits to patients and the sustainability of their organization will far outweigh the perceived hurdles. Collaboration will be the key to reaching these goals, and if organizations are willing to share the load with their industry peers, the biopharmaceutical  industry, and more importantly its patients, will share in the success.

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Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

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Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

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Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

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