The pharmaceutical industry’s landscape is changing. As the industry shifts toward more complex manufacturing processes with biologics and cell & gene therapies, there’s greater pressure to increase operational speed, reliability, quality, and safety. Yet traditional manufacturing execution systems fail to meet the industry’s changing needs and challenges.
In an effort to address this important issue, Apprentice's Senior Product Manager, Emilee Cook, recently collaborated with fellow industry leaders to create an MES of the Future manifesto for the BioPhorum group. BioPhorum leads more than 90 industry-changing initiatives and brings together thousands of subject matter experts to collaborate on challenges in existing and emerging topics that affect the whole industry.
This manifesto highlights the gap between the current generation of MES solutions and addresses the challenges facing the biomanufacturing industry. As a call to action for the biopharma industry, it is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions and inspire change.
Complimenting her work on the manifesto, Emilee has presented on what the MES of the future looks like at Bioprocessing International West and Pharma MES USA, covering the following topics:
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.
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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