Case study

Using DPMM to build the future digital journey

Gilead
biophorum resized biophorum resized merck 07 37
Rockwell Automation

The context

BioPhorum’s Digital Plant Maturity Model (DPMM) describes the five levels of maturity, from simple paper-based plants to the fully automated and integrated ‘adaptive plant’ of the future.

It enables IT professionals to have the right conversations with the right stakeholders about the opportunities and priorities to transform biologic operations for digital systems. It is built using real learnings from a team of BioPhorum member companies and it is being used by non-members and a significant proportion of members.

The 2018 DPMM update simplified the model by reducing the number of business dimensions and enabling capabilities (e.g., ‘manufacturing execution and process automation’ and ‘people and culture’) and increased consistency by leveling the scores across these. It also reset the vision for Levels 4 and 5. BioPhorum’s IT Digital Plant team also developed a Maturity Assessment Tool to be used alongside the DPMM.

Here, three industry leaders talk about using the DPMM and how it is helping their companies map their biopharmaceutical digital transformation journey.

How has the DPMM been adopted by your company?

“While I was at Merck, my job was to lead the architecture for its extensive manufacturing division,” said Sonia Banerjee, Global Lead for Portfolio Architecture and Quality Systems at Gilead. “I used the DPMM assessment with my IT colleagues to score sites and incorporate the results into their portfolio plans.”

She added, “But we realized that the DPMM wasn’t prescriptive and was subject to interpretation and so needed to include more guidance on how to evaluate each level. That was when the BioPhorum team put together the Maturity Assessment Tool.”

Now Banerjee is at Gilead, she is continuing to use the model. “We don’t have many manufacturing sites because a lot of work is done externally. So we worked with a consultancy to take the DPMM and create a one-plant model to evaluate our current and future state expectations. However, when we talk to our stakeholders and business partners, we lead with the DPMM approach as it is more recognizable as an industry standard.”

Yves Berthouzoz, Head of Biotech Operations IT and Global Development & Launch IT at Merck, said it had applied the DPMM across all of its healthcare and life science sites with a little customization.

The members recognize that having a joint interest in solving challenges and open participation enables the team to solve problems more easily than trying to achieve solutions on their own.

What are the benefits of the DPMM?

“If you are looking for a model to give you a picture of your network, the DPMM is simple, clear and provides a view across all your sites,” added Berthouzoz. “The five levels allow you to create targets and, if you need help, it gives you ideas of how to progress. This can be really useful when asking for support from your sponsor.”

Banerjee explained that there were significant benefits because industry’s thought leaders had developed the model. “These are expert practitioners who have brought their collective knowledge together. It’s not something that has been developed by consultants who maybe have an ulterior motive of selling you services or products.” She added that it also shows how everyone in our ecosystem is trying to solve the same problems. “It lets us align our thought processes, influence our vendors, and create collective synergies.”

Bruce Kane, Global Life Science Industry Consultant at Rockwell Automation, suggested that many parts of the DPMM can apply to other industries. “For example, I’ve promoted it to the oil and gas industry so companies can see where they are in their digital transformation journey. It provides lots of examples, the model lets you select the ratings, and the descriptions help people understand the different stages of the journey. As an equipment supplier, we’ve used the model with our customers to assess and plan projects to move along the digital transformation continuum.”

But it is not just during site assessments where the DPMM can add value, it can help when selecting external companies. “When I’m evaluating a vendor or consultant,” said Banerjee, “if they’re familiar with the DPMM, it gives me comfort that they have the right industry knowledge. For example, we were doing a feasibility assessment for a particular type of facility and the outside engineering firm said it was going to make some proposals rooted in the DPMM. That made it much easier for the firm to talk to me and get selected rather than someone just giving me a cost-saving approach.”

So why has the DPMM been so successful?

“The bottom line is that it’s based on the collective knowledge of industry thought leaders,” explained Banerjee. “These are real practitioners. The DPMM is not a consultant’s document where we are not quite certain whether they are a true practitioner in the field.”

The DPMM also stands out against other measurement models. “Other readiness measures are available,” said Kane, “but I think they’re quite one-dimensional, while the DPMM gives a broader, more complete picture. As a result, it provides good coverage of all the aspects of a modern life science biopharmaceutical manufacturing plant.

Berthouzoz suggested that although other options are available, the DPMM is commonly used as it is industry-built and simple.

“The bottom line is that it’s based on the collective knowledge of industry thought leaders,” explained Banerjee. “These are real practitioners. The DPMM is not a consultant’s document where we are not quite certain whether they are a true practitioner in the field.”

Final thoughts

“The DPMM is also a great onboarding document,” said Banerjee. “Those new to architecture or automation might not know what it entails, so the DPMM gives them a great insight. It’s also a yardstick against which we measure other maturity assessments.”

Kane added that as well as being a model to measure yourself against some desired future state, “it also provides an opportunity to measure one site, plant or factory against another site, plant or factory within an organization. This lets an enterprise paint a picture of what it needs to do to move along that maturity curve.”

Ultimately, Kane saw the DPMM as a roadmap. “As with any map, the first thing you must do is find out where you are and then figure out where you want to go. In this type of tool, there should always be an aspirational step. The DPMM is not only good at showing where you are but at painting a picture of where you want to be, of what’s possible. That’s why the DPMM is so powerful.”

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Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

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Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

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IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

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BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

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The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

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BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
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  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

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The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

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This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

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MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

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