Facility of the Nuture – Part I
Thomas J. Piombino, Vice President, Biotechnology Process Architect IPS
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Denition of nuture: 1) the new future
In the architectural and engineering world of biopharmaceuticals, we often refer to the design of a facility for the next generation of manufacturing as the facility of the future (FoF). The idea of the FoF began about 10 years ago, primarily focused on the manufacturing of antibody-based biologics. Many innovative facility and equipment design strategies have been employed and positioned as the FoF in that time. Customers are looking for the attributes that have defined FoF such as flexibility, predictability, cost-effectiveness, and scalability. In trying to achieve these FoF requirements, the industry has consciously taken an inward view and leveraged disruptive technologies, optimized formulations, closed systems and increased automation to improve facility layout and process efficiencies.
As we continue to develop our ideas around the FoF, it is appropriate that we ask ourselves if the future unfolding before us now is what we thought it would be when we started on this journey a decade ago. Is it practical to continue to inwardly look forward when peripheral topics and pressures are growing? Can the attributes and technologies that previously characterized the FoF stand up against the demands of the new future or “nuture?”
Our reality points to the fact that the next big disruption in the nuture will be outward facing, requiring a balance between technology and business continuity. If we do not begin balancing this now, it will be difficult to prioritize nuture opportunities; opportunities that might require a focus on three monetized vertical markets - Human Health, Animal Health and Planet Health.
The challenges to nuture thinking are many. We find many competing life innovations that create an overwhelming sense of practical contradiction and moral conflict. Gene therapy has opened up an entirely new line of therapeutic thinking that will necessitate change. We are reading about, seeing and experiencing the impacts of accelerating climate change. The Internet of Things (IoT) is providing massive amounts of data that need to be harvested and will ultimately alter a century of behaviors and instinct. Our historical dependencies on government regulation to solve big problems is no longer realistic in a global economy. The nuture will require personal investment in change that will have to take place over years and not generations. The nuture is a new future; we need to be ready to pivot, both mentally and physically.
How can your FoF planning overcome all this scientific and natural innovation?
- Recognize that business continuity planning must be a leading initiative in your organization
- Balance your inward and outward view of the FoF facility design
- Prepare for outward disruption and don’t wait for regulation to dictate the required changes
- Back check your FoF assumptions against the nuture’s requirements
- Prepare to pivot
- Standardize when and wherever possible and leverage that to get to market faster
- LEED is a great start but don’t let it be a list of limitations that block your imagination, aspirations and the needs of the nuture
About the Author
Tom has been in the EPCMV industry since 1995 and started with IPS in
1998. During that time, he has been 100% focused on the design and delivery of biopharmaceutical facilities from conceptual process architecture to process design studies and detailed engineering. His technical background includes process architecture, process engineering, mechanical engineering and estimating and construction management. At IPS, Tom developed the InceptioneeringTM and iCONTM products that IPS offers customers. He manages these on a day-to-day basis in addition to being an accomplished process architect for biotechnology projects. Tom is an SME of bioprocess facility design/equipment, including stainless steel, hybrid and single-use clinical and manufacturing facilities. Additionally, he has been working with clients on cell and gene therapy facilities.