Clarkston’s MES expert Lynette Nazabal recently attended the 2024 Pharma MES Conference in San Diego, California. The event brought together over 150 Manufacturing Execution Systems (MES) and manufacturing experts to discuss driving digitization in manufacturing, with a focus on flexibility and scalability, change management and adoption, digital maturity and Industry 4.0, advanced analytics and AI, and MBR standardization and governance. 

Driving Digitization in Manufacturing

This year’s Pharma MES 2024 showcased some exciting advances around manufacturing automation and analytics and how Manufacturing Execution Systems (MES) create more visibility into the operations on the shop floor. The MES user community for pharma and biotech companies presented some key insights on master batch record (MBR) standardization, change management best practices, data and analytics, and the benefits of a predictive plant. In addition, MES vendors also provided updates on some of the key trends and how MES can take companies one step further to reach complete digitization within manufacturing. 

One of the key themes coming out of the conference was: “What are the benefits of a digitally mature manufacturing plant, and how does MES fit in?” Several roundtable discussion topics centered around driving digitization in manufacturing, covering data management, implementation best practices, data flow and strategy, and effective data utilization. Below, we outline some of our takeaways from Pharma MES 2024. 

Key Takeaways from Pharma MES 2024 

1. A Flexible and Scalable MES 

As pharmaceutical products and manufacturing facilities become more sophisticated and complex, the current MES landscape will also need to become more flexible and scalable to accommodate these changes. MES will need to evolve to support more complex processes, like Cell and Gene Therapy, and support “flex” facilities, where multiple modalities and products will need to be manufactured. MES offerings are expected to become more composable as they reimagine their design and control philosophies to adapt to the changing industry. Composability and a new control philosophy built with a bottom-up approach will enable emergent behavior to develop in the MES solution by empowering different teams to define workflows in a way that best works for them, streamlining the organization’s overall manufacturing efficiency.

Changes to design practices will also be important when adapting MES systems to the modern pharma manufacturing landscape. The traditional approach of designing the system for all anticipated requirements and adjusting workstreams to conform to pre-defined requirements will need to be replaced with an agile approach focused on constructing and deconstructing the system based on requirements needed for the current state of the facility. 

2. Emphasis on Change Management and Adoption  

As organizations across the industry continue to implement new MES solutions and improve existing systems, proper change management practices and organizational adoption will need to be emphasized and prioritized. In addition, understanding if your plant is ready for change and establishing a baseline for maturity can drive how quickly and in what capacity your organization can advance. Proper change management is equally important for initial implementation, as it’s during the continuous improvement process and allows MES to be the incredibly powerful tool that enables efficiencies across all parts of the manufacturing group.

Proper organizational adoption practices are also important and necessary activities for end users to utilize the gains in productivity that MES enables. It’s important to communicate a “vision” of how your transformation is achieved and what the measure of success looks like in order to have the extended organization championing toward the same goal. Company culture also plays a huge factor in a successful transformation that can be sustained when “new behaviors are rooted in social norms and shared values” as well. It’s important to demonstrate the organization’s new approaches, behaviors, and attitudes that have helped improve performance. Instituting change champions to drive consistency is key but we must not forget that the legacy of a vision must be carried forward to future leadership.

With the importance of optimizing MES so that it may mature over time, having an experienced implementation partner that uses the current industry best practices is a fundamental part of the implementation process. 

3. Striving to Achieve Digital Maturity and Meet Industry 4.0 

Digital maturity and Industry 4.0 are often at the forefront of any organization looking to implement MES. The real-time predictive plant that digital maturity enables, and that Industry 4.0 describes, requires the correct decisions to be made before, during, and after the initial implementation of MES. Understanding where MES strategically fits within the digital supply chain is key to unlocking the most benefits while leveraging a completely integrated solution.

By developing a digital plant strategy, you can unlock meaningful integrations while also identifying key areas of excess technical debt that can potentially be streamlined. Prioritizing proper data architecture, identifying siloed systems and data integrations, and being able to define a blueprint toward digital maturity and Industry 4.0, amongst other best practices, are important when implementing MES in today’s environment. Being able to apply these best practices to systems that have already been implemented – and are looking to make progress towards digital maturity – is just as, if not more, important. 

4. Leveraging Manufacturing Data to Support Analytics and AI 

Manufacturing floors produce incredible amounts of data. Properly capturing and storing that data enables advanced analytics that can be leveraged in a multitude of ways. One of the ways shop floor data can be leveraged is through predictive maintenance models, which aim to reduce excess costs associated with traditional routine or time-based maintenance programs by only performing maintenance when a piece of equipment has been predicted to be very close to failure based on the captured floor and production data. As large data models continue to progress, MES vendors are looking to be able to provide real-time feedback and recommendations on production data, including recommending courses of action when anomalies are detected. 

5. A Focus on Master Batch Record (MBR) Standardization and Governance 

To enable a fully mature MES solution and maximize the potential benefits of the system, MBR standardization and governance have become two of the most important initiatives that an organization can utilize to meet its goals. MBR standardization is an important activity that enables users to utilize all the capabilities that MES has and not just a paper-on-glass system. While enabling this during initial implementation is preferred, activating this initiative during continuous improvement efforts can be accomplished through a thorough review of all processes and MBR workshops with various functional groups and an agreed-upon set of design principles aimed at removing as much unnecessary information and individualized content as possible, enabling a lift and shift methodology. This must be followed by an instituted MBR governance, ensuring adherence to these standards and that any new MBRs are designed using the standardized approach. 

What’s Next for MES  

This year’s Pharma MES Conference was another great opportunity for industry leaders within the MES user community to share their approach to driving digitization in manufacturing — through innovation and pushing the limits of what MES is capable of. While challenges still exist, hearing perspectives on how other companies are navigating through these challenges and utilizing MES efficiently continues to provide strategic value within the MES user community.  

MES vendors also demonstrated advances in augmented reality and integration capabilities and how they’re meeting the challenge of providing flexibility. As the industry continues to emphasize optimizing manufacturing operations and creating flexibility, the MES user community continues to look for strategic partners to lead them through their digital transformation journey and provide best practices on how MES can be utilized optimally and efficiently. 

Reach out to Clarkston to learn more about our MES consulting services today. 

Contributions from Simon Ziccardi