Biopharma’s path to MES in the Cloud

The biopharmaceutical industry is at the cusp of a major digital shift as cloud-based manufacturing execution systems (MES) gain traction. While adoption is still in its early stages, the potential to leverage emerging technologies promises enhanced operations and greater efficiency. However, this transition comes with its own set of challenges. Industry collaboration – particularly between biomanufacturers and MES partners – is key to overcoming these hurdles.

To explore these opportunities and obstacles, we spoke with two experts, Ciera Clayton from BioPhorum and Kortney Gunther from Körber, who shared valuable insights into the future of MES in the cloud.

It’s a pleasure to have you both with us today! Before we dive into our discussion on MES in the cloud, could you please start by sharing a little about yourselves?

Ciera: Of course, my name is Ciera Clayton, for the last two years, I have worked as a global change facilitator in BioPhorum, where my current role is facilitating the MES of the Future program in the IT Digital and Data Phorum, and the Risk and Business Continuity program for the Supply Resilience Phorum. Prior to this, I spent nearly 10 years working for a CMO in various roles across production and business projects, specializing in agile leadership and change management. I led multiple technical projects, such as the global implementation of serialization track and trace systems.

Kortney: I joined Körber in September 2021 as a Senior Product Manager after working in healthcare IT for 16 years. My focus has been on advancing technology, improving patient safety, and removing analytical barriers caused by outdated paper processes. Naturally, I was excited to tackle some of these challenges in pharma/manufacturing.

Ciera, can you briefly explain what BioPhorum is and its vision and mission for our readers who may not be familiar with it?

Ciera: BioPhorum is a global biopharmaceutical manufacturing industry collaboration comprising over 150 member companies and more than 7,500 active participants. Our members are experts from major manufacturers and their key supply partners, representing a significant portion of all biopharmaceuticals manufactured worldwide. Our mission is to provide a safe space for industry leaders to pool their knowledge, practices, and ideas, creating synchronized change through our 12 Phorums.

Kortney, how is Körber involved within the BioPhorum network?

Kortney: Our participation with BioPhorum spans multiple areas, especially within the IT Digital and Data space. We actively participate in several Phorums and Workstreams, contributing to publications and staying aligned with industry developments. Personally, I’ve been involved in the MES of the Future Workstream for over a year, which has allowed us to shape the future of MES and ensure our strategies resonate with the broader industry direction.Workstream for over a year, which has allowed us to shape the future of MES and ensure our strategies resonate with the broader industry direction.

What has your experience been within BioPhorum so far, how valuable is it to hear the voice of the customer from our customers and non-customers? 

Kortney: As a Product Manager for PAS-X MES, I consider the voice of the customer to be the most critical input in shaping product development. During my Scaled Agile Framework training, I came across the quote: “If customers don’t like it, nothing else matters.” This has been a constant reminder that no matter how well we engineer, design, or market a product, if it doesn’t meet customer needs, we’ve missed the mark.

My involvement in the MES of the Future Workstream at BioPhorum has been incredibly valuable, especially in aligning our goals with overall industry trends. I joined the MES of the future workstream around the time that the MES of the Future Manifesto was published and within Körber Pharma Software, I am specifically focused on MES as a Service. It was reassuring to see that the problems we were trying to solve with our SaaS delivery model aligned with the collective mindset of other industry experts, many of whom are MES customers. It was very timely as it coincided with a shift that we had been seeing for some time in the MES market towards cloud-based technology and flexibility, integration, reduced deployment and downtime, and overall solutions that lowered the barriers of costs. I frequently reference the Manifesto in discussions, which underscores the quality and relevance of the work produced by this group. It has been a powerful tool in guiding many strategy discussions and ensuring that we remain customer-centric in our development efforts.

The MES of the Future team has published three white papers this year. Can you tell us a bit about the team, these papers and how they were developed?

Ciera: The MES of the Future team sits within the IT Digital and Data Phorum and includes over 120 members from 30 different biomanufacturing and MES supply partner organizations. This year, we published three white papers addressing key challenges in MES integration, data management, and cloud adoption. The ideas for these papers came from the challenges outlined in the MES of the Future Manifesto, which is a call to action for supply partners like Körber to listen to the needs of the biomanufacturing community and build their roadmaps for MES based on this consensus voice.

The first white paper, “Unlocking Efficiency”, provides guidelines for integrating MES with other software solutions to drive operational excellence. The second, “Navigating the Data Maze”, addresses the complexity of data management within MES platforms, offering a practical guide to identify, define, and rationalize priority data. The third, “Mapping the Pathways to MES in the Cloud” serves as a comprehensive guide to help organizations through their cloud journey, including a self-assessment toolbox.

Each white paper provides organizations with the tools and knowledge to develop stronger, more resilient business cases and project plans, ensuring a smoother transition and implementation. They are designed to benefit both the supply partners and manufacturers.

They were all built on industry consensus with up to 25 different companies contributing to their content. I must say the supply partners like Körber were particularly helpful in challenging the biomanufacturers to really consider and contextualize their problems within these spaces so that they could understand the voice of the customer better and help work towards building solutions that fit this need.

The latest BioPhorum whitepaper on MES and the cloud was recently released at the Pharma MES in Berlin – Congratulations! What were the most pressing industry challenges that inspired the creation of this document?

Ciera: Thank you! The most pressing industry challenge that inspired the paper is the need for biopharmaceutical organizations to leverage emerging technologies and digital solutions, like cloud-based systems. While many organizations are already integrating cloud-based solutions for various enterprise systems, the adoption of MES for manufacturing operations on the shop floor has been slower.

This transition raises concerns about security, connectivity, availability, and integration with local systems. Our white paper aims to increase the pharma industry’s comfort and confidence with implementing cloud systems and provides a roadmap for transitioning MES from on-premises to the cloud.

These challenges persist alongside the obligation to maintain the supply chain system reliability and manage operating costs responsibly and we know things like availability of capital spends for refreshing obsolete hardware and systems is often limited. Biomanufacturers have the challenge of hiring and retaining a team of IT professionals to manage traditional on-premises infrastructure.

So, to keep pace with technological advancements in a cost-effective and efficient manner, organizations require access to innovative technologies and tools. In response to these challenges, cloud-based infrastructure then emerges as a promising solution. This paper aims to increase the pharma industry’s comfort and confidence with implementing cloud systems and equips biomanufacturers with the essential roadmap for seamlessly transitioning their MES from on-premises into the cloud.

Rather than focusing solely on the benefits of adopting a cloud-based MES, the whitepaper compares cloud and traditional MES solutions. Can you explain the reasons for this approach?

Ciera: We wanted to provide comprehensive information that allows readers to decide if and how a move to MES in the cloud is right for them. The paper outlines the benefits and challenges of different cloud types, detailing aspects like infrastructure, control, and security. This approach helps organizations gain a comprehensive understanding of important nuances.

The “Cloud types and benefits” section outlines the journey to the cloud: from traditional through transitional, and into the visionary MES of the Future. The transitional pathway encompasses various aspects of the cloud that contribute to completing the journey. There are eight different cloud aspects, such as application architecture, tenancy, software release and update methodology etc. In this section, each of these aspects are mapped out detailing for example what does a traditional MES tenancy look like vs cloud-based? What are the benefits of traditional MES tenancy vs cloud-based? And what are the challenges and limitations of a traditional MES tenancy vs cloud- based?

The goal is to provide a comprehensive roadmap for organizations navigating the dynamic intersection of MES and cloud technology.

How does the cloud white paper provide guidance for biomanufacturers when evaluating cloud-based MES solutions?

Ciera: The paper serves as a starting point for business cases or evaluating ongoing programs. It includes business considerations, myth-busting guidance, and a self-assessment toolbox to help organizations build a roadmap for their cloud transition. It also details the personas in an organization impacted by this transition, listing their pain points and relationships with the barriers to change. This information helps create business buy-in and caters to the needs of different stakeholders.

We also provide a self-assessment toolbox to help your organization build a picture of where you are now with your transition to MES in the cloud and a road map of where you are heading in the coming years.

The guidance in this document can help improve alignment between your organization and supply partners, enhancing transparency, reducing risk, simplifying integrations, and hopefully pushing you towards a right first-time implementation.

What were specific insights or recommendations in the whitepaper that resonated with you as a vendor?

Kortney: The whitepaper’s educational value in managing barriers to cloud adoption resonated with me. It references the “Diffusion of Innovations Model” and the “Force Field Analysis,” which are valuable in evaluating organizations and the drive for change. I have been pushing cloud topics globally since I landed in biomanufacturing with the knowledge that I was dealing with the complexities of GXP systems, and it is important that we as MES vendors continue to ease this burden for our customers.

Moving on to the “Force Field Analysis”, it was very insightful to see this concept for use in the case for/against cloud. A tried-and-true method that is still extremely relevant in evaluating organizations and the drive for change. Furthermore, the examples documented in the “Force for Resisting” and the “Force for Change” are again aligned to the challenges that we as an MES vendor want to solve for our customers.

The “What will you hear/need to know” section prepares stakeholders with critical considerations, potential challenges, and strategic benefits of cloud adoption.

How do you balance the need for innovation with the stringent regulatory requirements in the pharmaceutical industry?

Kortney: The pharmaceutical manufacturing industry has been slow to adopt cloud-based technologies due to regulatory constraints. Our white paper urges regulators to rethink these processes to enable the industry to benefit from cloud-native solutions.

Ciera: Yes, that’s true. The pharmaceutical industry is unable to fully leverage cloud-native technology due to regulatory constraints, particularly around automated updates. Every update must go through a stringent QA process, with each change carefully checked and validated.

The current level of regulation, while necessary, puts us behind other industries in terms of technological advancements. The white paper is a call to action for regulators to rethink these processes, proposing a compromise or an alternative approach to validation that would enable the pharmaceutical sector to benefit from cloud-native solutions.

Could other industries like pharma benefit from the work you're doing, or is it specific to biomanufacturers?

Ciera: The information we share is relevant to the broader pharmaceutical environment, including contract manufacturing organizations. Although we are called BioPhorum and have traditionally catered to the biopharmaceutical market, our scope extends to areas like IT, digital, and data.

In the future, what do you see as the most critical next steps for biomanufacturers and vendors to address collaboratively?

Ciera: Collaboration is key. We need to contextualize the problems and reasons for our drivers to the supply partners more accurately and with global consensus. We also need to address the operational processes associated with MES and ensure organizations are ready for digital maturity and workforce enablement. By sharing knowledge and engaging with MES supply partners, we can build a clear path towards the MES of the Future.

Kortney: I think it is important to have a space where biomanufacturers, vendors and other industry partners work together seamlessly. So ecosystems like BioPhorum are essential for driving innovation and ensuring the best possible outcomes for patients. 

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