NEWS

Welcome to the MES of the future

1 February 2022
Information Technology
BioPhorum

Manufacturing execution systems (MES) provide many benefits to the regulated manufacturing of biological products but are not always successful in helping companies overcome their challenges of meeting demand, reducing costs and increasing quality across drug portfolios. Current approaches are also unsuitable for certain scenarios, e.g., small-scale manufacturing plants.

At the same time, the biomanufacturing industry has not created a common view on its future MES requirements to support the development of products/services by MES vendors.

The impact of this situation on biomanufacturers can be considerable. For example, the scarcity of the highly technical skills required to adapt solutions can adversely impact time and cost, and industry needs are not understood or built into MES product roadmaps.

BioPhorum’s MES of the future manifesto aims to resolve this situation. It articulates the gap between the current generation of MES solutions and the needs of industry and outlines a realistic and achievable vision for the MES of the future that will meet the needs of biomanufacturing plants.

Call to action

The manifesto results from a first-of-a-kind collaboration between manufacturing IT leaders, technology specialists and MES vendors. It is a call to action for all vendors of MES products to understand the needs and challenges faced by biomanufacturers in the deployment, configuration, and support of MES solutions in this highly regulated industry.

“MES for biopharmaceutical manufacturing is a critical part of our drive to efficiency, quality and performance,” said Dr Peter Iles-Smith, Senior Program Director, Security & Cloud Transformation at GSK. “However, MES remain complex to implement, expensive to change and relatively inflexible – especially in today’s rapidly changing IT world. The MES of the Future manifesto and the cross-company collaboration behind it represents a call to arms for the industry to ask, and answer, questions about what we need, how it should work and how it can be managed.”

The paper also considers how biomanufacturing will evolve alongside technological advances to create the need for an MES of the future and analyzes the experiences of BioPhorum members that have implemented MES solutions in their current generation of biomanufacturing plants. The findings of this analysis, combined with the direction of new manufacturing and digital technologies, define the needs for MES that are capable of deployment, configuration, and support.

The benefits of this work to biomanufacturers include an enhanced approach to system update/deployment, zero downtime, better data availability, and improved flexibility of use and deployment. The benefits for vendors are equally high; they will understand directly from industry a consensus view of what is needed from them in the near future and over the longer term.

“I see the importance of the MES manifesto in three different areas,” said Gustavo Martin, IT DP Product Manager for MES and Warehouse Solutions at Roche. “It will ensure that the route we are following is the right one. It will also facilitate our internal change control process, making faster and right decisions and ensuring added-value investments. Finally, it provides a common and long-term discussion agenda for continuous dialog with our vendor, defining the product strategy.”

The biomanufacturing industry faces unique challenges in meeting demand, reducing costs, and increasing manufacturing quality across current drug portfolios. New biological medicines are also being developed that will require a radical shift in manufacturing processes. As a result, industry must digitize and automate manufacturing processes and make full use of innovative technologies; the role of MES will be crucial to its success.

The manifesto is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions that will outline their roadmaps for future systems development. This is an opportunity for vendors to align the necessary and long-awaited product innovation with true business needs.

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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.

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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.

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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.

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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.

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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.

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Publications

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

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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.

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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.

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

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