How our Digital Membership is unlocking the digital transformation of pharma for industry 5.0

Industry 4.0 has driven vast changes across virtually the entire UK economy. As we enter the next phase of industry evolution, both the rate and scope of change are only set to accelerate. 

Industry 5.0, and the integration of novel technology for human-machine collaboration, will bring a step change in productivity, carbon efficiency, and compliance that will revolutionise pharma, with benefits for patients, the planet, and the bottom line. 

At CPI, we have taken on grand challenges to help drive pharma manufacturing towards a future that is efficient, sustainable, and has low impact on the planet. These include transforming tablet production and delivering automated just-in-time clinical supply. Our newest grand challenge, the Digital Membership, links them together through a vision to create the digital pharma factory of the future.

The Digital Membership is based at our Medicines Manufacturing Innovation Centre in Glasgow. It delivers vendor-agnostic enterprise architecture designs that demonstrate the effective use of connected data, systems, and technologies to achieve key pharma objectives such as real-time release. We can then apply these designs across other digitally focused grand challenges to demonstrate and de-risk the solutions. 

A collaborative drive towards the future

Unlocking Pharma 5.0 will require digital transformation and collaboration across the industry. While there is currently a large amount of market interest, guidance, options, and opinion, the landscape is confused with multiple solutions and sporadic application of digital best practices. This situation hinders progress, but aligning on common data models, enterprise architectures, and best practice guidelines for implementation can accelerate the adoption of digital manufacturing and help overcome these barriers. 

The success of any industry alignment or standardisation initiative depends on collaboration, which is why we opened our Digital Membership programme. It provides access to a community of diverse collaborators from pharma companies, technology providers and regulators, connecting people with problems to people with solutions. 

This pre-competitive community is a representative cross-section of the pharma industry and those who support it. It is open to all, has simple running and cost structures, and regular meetings with partners. Members work together to overcome challenges associated with digital transformation, contributing their different areas of expertise and turning them into effective solutions for the industry. 

The programme focuses on delivering working software prototypes and physical demonstrators to de-risk the architecture designs. Two key factors enable this goal: the agile (Scrum) project management framework, which drives fast and efficient collaboration, and a digital architecture repository, which enables open-access collaboration while ensuring strict version control. 

The community helps set priorities in different market segments and provides access to the broader scope of work, an important tool for smaller companies. Any member of any size, whether an entrepreneur, SME, or large pharma company, can benefit from the membership. 

What do you get from the Digital Membership?

Digital Membership is provided through the Medicines Manufacturing Innovation Centre, where our expertise is implementing cutting-edge digital technologies. Here, we can de-risk pharmaceutical innovation and new technologies through shared costs, resources, and demonstration in a regulated facility. 

It is a space for collaboration and training with in-house expertise in pharma and compliance and state-of-the-art facilities. We anticipate it will become a ​‘Digital Lighthouse’ for the pharmaceutical industry by demonstrating how a compliant, connected ​‘Digital Pharma Factory’ operates. 

The key outcome of membership is a reference enterprise architecture: a digital blueprint to address a specific challenge in the drive towards digital pharmaceutical manufacturing and Industry 5.0. The ​‘full stack’ encompasses the new architecture’s initial vision, motivation, and strategy, as well as all the business services, applications, technology, and data required to make it a reality. 

These standardised enterprise architectures for smart factories are built to enable the rapid deployment of digital tools across the entire industry to improve patient outcomes, sustainability, flexibility, and value. We have confirmed its suitability for small-molecule drugs, both in the pure, active ingredient form and final product, as well as downstream processing for biologics. 

Currently, our Digital Membership includes GSK, AstraZeneca, The National Physical Laboratory (NPL), Tulip Interfaces, Siemens, The University of Cambridge, Atos, Quotient Sciences, Industrial Technology Systems Ltd (ITS Ltd), The University of Strathclyde, Wyoming Interactive, Capgemini, Amazon Web Services (AWS), Thermo Fisher Scientific, and PwC. 

The next phase of pharma evolution

We’ve completed our first year of operating the Digital Membership. Members can network with pharma companies, tech companies, and service providers and get access to the first-year data. They can also contribute to the direction of our second year, influencing the future of digital manufacturing in pharma. 

In this next phase, we plan to add new product types like complex RNA and oligo therapies, cell and gene therapy, and the supply chain. We will address deployment in brownfield sites and data transformation at early vs late stages for business capabilities. New business objectives will include predictive performance and maintenance and the integration of IT with operational technology (OT) systems. 

This next phase of membership started at our meeting in mid-May 2024 and is currently open to new members. 

Are you interested in shaping the next digital transformation in pharma? Contact our experts.