The Growing Impact of Flexible Biomanufacturing Solutions

A Q&A with Matthew Weaver of Rockwell Automation

Digital transformation in pharmaceutical manufacturing is accelerating. For the past decade, the industry has steadily moved away from traditional large-scale, volume-driven production toward more flexible, adaptive manufacturing practices that better serve patients needing complex, targeted medicines. In this Q&A, Matt Weaver, Vice President, Global Industry – Life Sciences, at Rockwell Automation, discusses how modern-day manufacturing solutions are defying economies of scale through the utilization of advanced technology.

What factors are driving pharma manufacturing to adopt more flexible solutions? 

The shift towards more flexible solutions within pharmaceutical manufacturing is a response to the growing demand for personalized care and medicine. An example of this could be cell and gene therapies, which require smaller, more customized production runs. This unique personalization can prove to be a challenge for traditional large-scale facilities, as they are often unable to support this level of agility due to their structure. 

Another driving factor in this shift is that biopharma manufacturers are placing an increased prioritization on both scalability and adaptability. This means identifying systems that can be easily reconfigured at a moment’s notice to produce multiple products and quickly respond to changing market demands. 

To accomplish this, manufacturers are utilizing data-driven advancements in digital technologies and AI to improve process efficiency, enhance production precision, and reduce operational variability—key capabilities that support the shift toward more personalized and flexible manufacturing.

Can you describe what the ‘Facility of the Future’ is, and its context within pharmaceutical manufacturing?

The ‘Facility of the Future’ is all about creating smaller, more flexible manufacturing sites that are located closer to the patients and markets they serve. These facilities are designed to be easily reconfigured, making it possible to produce a variety of complex products—like cell and gene therapies—under one roof.

This approach isn’t entirely new—it’s the result of years of innovation and learning across the industry. What makes it different is that it’s scalable and repeatable, helping manufacturers bring products to market faster while keeping capital costs in check. 

How is the “batch of one” philosophy impacting traditional economies of scale in pharma?

For a long time, the pharmaceutical industry relied on the same economic model: large-scale production to drive efficiency. But as technology evolves, those economics are shifting. Meeting today’s demand, especially for more personalized treatments, calls for a different approach—something closer to a “batch of one” mindset. Making that work means putting the right systems in place: connected, automated processes that can handle smaller, more customized batches without losing efficiency and ease of configuration. 

Why is digital tech transfer becoming increasingly important in biopharmaceutical manufacturing?

 With the rise of the “batch of one” approach, digital tech transfers are playing a bigger role in biopharmaceutical manufacturing. At its core, it’s about making the handoff from development to production smoother by transferring data and processes in a clear, structured way. This is especially important for complex therapies, where consistency and efficiency are critical.

By going digital, companies can cut down on manual steps, reduce the chance of errors, and keep projects moving faster—ultimately helping new treatments reach patients sooner.

Can you elaborate on how digital and automation technologies are becoming essential assistants?

• Real-time Monitoring and Control: With advanced technologies such as IoT and AI, biopharma manufacturing processes can be monitored in real-time over critical parameters such as temperatures, pH balances, flow rates and more. This allows for immediate detection and correction of deviations, helping to ensure consistent product quality.

• Predictive Maintenance: Empowered by AI-driven insights, equipment failures can be detected and alerted to before they occur, creating a new opportunity for manufacturers to conduct predictive maintenance. By conducting routine and preventive maintenance, operations can experience smooth operations with a reduction in overall downtime. This is particularly important in a flexible manufacturing setup where equipment is used intensively.

• Advanced Training Tools: Through the utilization of augmented reality and virtual reality, operators can experience immersive training experiences such as component or machine assembly, helping them understand and manage the complexities of flexible biopharma manufacturing systems more effectively.

• Digital Twins: Digital twins can generate a complete virtual replica of the biopharma manufacturing process, allowing operators to simulate and optimize production of therapies without the costly potential of disrupting actual operations. With this reduced risk, operators can plan and execute complex manufacturing layouts and tasks with greater efficiency.

• Automated Changeovers: By integrating automated systems into the multiproduct biopharma manufacturing process, the time and errors associated with changeovers between batches can be mitigated. Autonomous mobile robots and advances in the capability and flexibility of robotic arms can handle the physical aspects of changeovers, while software solutions can manage the configuration changes.

• Enhanced Connectivity: By leveraging advanced communication protocols and centralized control systems, all essential equipment and systems within the creation of a drug can be seamlessly integrated, reducing overall complexity in managing interconnected devices.

• Guided Work Instructions: Operators within the biopharma manufacturing space are tasked with complex tasks, often requiring manual intervention, creating the potential to introduce errors. By developing insightful digital work instructions, enhanced with graphical aids, operators can walk through complex tasks step by step, thereby mitigating the humanistic risks. 

About the Author

With over 15 years of industry experience, Matt brings a strategic mindset to the Life Sciences industry — helping organizations achieve operational excellence through digital transformation. As Global Vice President of Life Sciences at Rockwell Automation, he guides clients in navigating complex challenges with tailored solutions that align with their unique goals. By blending innovation with business insight, he empowers companies to modernize operations, embrace change, and drive long-term success in an increasingly connected and competitive world.