On Shire, Single-Use and Simplicity

CRB’s Eric Unrau talks about what worked at Shire Lexington, and what limitations need to be overcome for single-use systems.

By Paul Thomas, Senior Editor

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Drug manufacturing facilities of the future will need to be a lot smarter and flexible than those today. They will be “smaller, more nimble, more flexible, more responsive to evolving processes and changing purposes,” says Eric Unrau, Director of International Operations for CRB Consulting Engineers. “This makes for overall reduced project investment, and faster project schedules for new facilities. The operational costs are lower, with a reduced environmental impact versus a more traditional process and facility. When done correctly, it is lower risk from a product quality and patient perspective and also a regulatory perspective.”

Single-use equipment and systems will be a major facilitator of such facilities, Unrau acknowledges. But they won’t be the be-all and end-all. They need to be put into context. We speak with Unrau about his company’s work with single-use, including Shire’s recent award-winning facility in Lexington, Massachusetts, and ask him to clarify what factors might limit the adoption of single-use.

PhM: First, a general question: When you think of the “facility of the future,” what do you think of primarily? How might your vision differ from that of others?

E.U.: In general, the thought is around a process which leverages the best of current compliance thinking, operating philosophy, closed system designs and new technology in a way that allows for the facility that houses it to be simplified. What we call the “FutureFacility” will have risks clearly identified and adequately mitigated. Equipment will be used most efficiently with emphasis on value-added operations. Cleaning and sanitization operations (value negative) and idle time (value = 0) will be minimized. Net water utilization will be minimized by reducing waste. Bioprocessing will be more streamlined and more continuous than traditional batch processes seen yesterday.

The FutureFacility will be smaller, more nimble, more flexible, more responsive to evolving processes and changing purposes. This makes for overall reduced project investment, and faster project schedules for new facilities. The operational costs are lower, with a reduced environmental impact versus a more traditional process and facility. When done correctly it is lower risk from a product quality and patient perspective and also a regulatory perspective.

A number of companies, on both the consulting and manufacturing sides, are interested in these concepts and many have similar goals of reduced cost and schedule. One of the things which makes our vision different is our holistic approach in designing the facility. We focus on the particular project needs and listen to our client’s requirements, and then leverage numerous technologies, business drivers, design, quality, maintenance, safety, environmental and operations initiatives to incorporate all those aspects into the project.  The end result is a facility that can be more flexible, affordable, and faster to bring up and operate.

PhM: You’re an advocate of fully closed processes. Why exactly? What are some benefits of fully closed processing that many people might not realize?

Shire LexingtonE.U.: Simply put, closed processing protects the product from the room environment. If that is true, then this allows the facility requirements to be dramatically reduced in terms of product protection—in other words, the facility is a non-impact system (as defined in ISPE’s Baseline Guide). As the facility is no longer protecting the product, it can be simplified—better, faster, cheaper—and not just one of these, but all three. Process closure is safer and cheaper. Benefits can be numerous and depend specifically on the technology, product and project requirements. However, in general they can be: reduced risk of product contamination, reduced project cost and schedule, improved operations, and reduced operational costs. There are many others, but that is a start.

PhM: Shire’s Lexington facility has received attention and accolades for, among other things, housing the first commercial 2,000-Liter bioreactor. In your mind, what is truly groundbreaking about the Lexington facility that will be imitated in years to come?

E.U.: This was a great project and one that CRB was excited to be a part of. Shire pushed the envelope by implementing single-use systems in evolutionary, pioneering ways. In addition to setting the vision of a groundbreaking facility, Shire also had a number of other goals in the project, leveraging complementary areas of scope on the project such as design and construction of the facility vs. design and fabrication of the equipment is one area. Early occupancy of the building was achieved through close collaboration of design, vendor, quality and construction teams. This allowed for early procurement of single-use systems, early commissioning of those systems at the vendor’s site, and even improved operator training prior to equipment coming to the site. There are other areas specific to the project which were highly beneficial to Shire in areas that are client confidential.

PhM: That Shire project was also a case study in how a commercialization timeline can be squeezed. CRB believes that timelines can be reduced significantly on average—what is this based upon?

E.U.: Experience! Despite needing to develop new technologies, the Shire project timelines were enviable compared to most traditional bioprocessing facility design projects. Schedule reduction on a project, and specifically focus on the ability to compress project schedule is nothing new. The differences in this particular case came from a few different sources. Closed processing, which allows for a simpler facility, means there is less to design, less to install, less to start-up and commission. All of this together leads to savings in time and money. Single-use systems can offer expeditious timelines for equipment procurement as well as the potential offsite commissioning and operator training, depending upon the systems and vendors used.

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