Exponential change doesn’t come from incremental improvements, according to Michael Gagne, founder and CXO (chief experience officer), ARTeSYN Biosolutions. This truth seems especially relevant in bioprocessing, where companies are frustrated with existing supply chains, which are full of pain points and resistant to being improved link by link. Companies need a comprehensive solution. To eliminate multiple pain points all at once, companies need Bioprocessing 4.0.

Gagne states that the “pains driven” approach to moving to a facility of the future does away with the biggest obstacle to exponential progress: complacency in supplier selection or product design. End users or original equipment manufacturers, he argues, require a push to reject these inefficiencies and respond with urgency when given a chance to collaborate on something that fits their needs and promises to advance their interests. Suppliers, he continues, should emphasize cooperation with end users, and not competition with their peers, when working toward a pains-driven solution.

“Many manufacturers are stuck in trying to simply optimize what they are doing, rather than take the leap and make a paradigm shift to a facility of the future,” Gagne continues. “The right mindset is the key to really make this transition. That and a deep understanding of the major problems plaguing biomanufacturing today. If traditional facilities are so great, why do they inspire so little confidence among the biomanufacturers who are pioneering cell and gene therapies? Why is the next-generation facility—the facility of the future—becoming a standard instead of remaining an anomaly in biomanufacturing? The traditional approach has flaws that have pretty much become a natural part of biomanufacturing, but that need not be so.”

Typical flaws, or pain points, are instances of downtime. According to Gagne, downtime can be caused by parts washing, cleaning validation, leakage, high hold-up volumes, kinking in single-use (SU) tubing, and human error. He adds that all these sources of downtime can be eliminated at once, provided biomanufacturers embrace an exponential approach.

“We have already seen an exponential approach to the facility of the future design enabling a 10-fold reduction in the cost of setting up and running a bioprocessing facility for a global manufacturer,” asserts Gagne. “That’s because we didn’t try to squeeze more out of the manufacturer’s existing solutions. Instead, we chose the more challenging route of searching for the most forward-looking single-use technology. Even with the issues accompanying single-use technology, it’s the far better option.”

If you listen to the market and where it’s headed, anything short of a cutting-edge leap won’t suffice,” he continues. “Confronting the rising wave of cell and gene therapies as a viable clinical option will require a substantial shift in the industry’s approach to everything from facilities to hardware to software design. It will push end users to reconsider their reliance on decades-old technology and challenge their perception of how far single-use technology has advanced today and how to make it work for them.”

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