Flexibility of Biopharmaceutical Facility Construction Is the Future for Swift, Agile Market Responsiveness

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It’s an odd question to contemplate, because we’re conditioned to think of facilities as large, inflexible, brick-and-mortar, or steel structures. These structures, by nature, are rigid and static. But markets and demands are dynamic, ever-changing and rapidly progressing.

If manufacturing businesses, and the facilities that house them, are too immobile and unable to adapt or scale, market penetration and sales potential will be limited and quickly hit a ceiling (not to mention four walls).

Instead of the antiquated notion: “If you build it, they will come,” the objective should be to find a faster, more flexible way to bring the facilities, manufacturing processes, and products to where the demand exists.

With traditional, site-built, linear construction, basic practices haven’t changed in decades and are increasingly incapable of keeping up at a pace that’s necessary for true market responsiveness and drug product innovations.

A new solution doesn’t just require significant modification in construction approach. The future is also in “podification,” at least for some very advanced and progressive industries.

Speed and adaptability are good medicine for Big Pharma.

Pharmaceutical and biotechnology companies are experiencing an evolution with respect to markets, regulatory requirements and new technologies. They can’t afford to stand by and stagnate. They need a new approach to process and cleanroom infrastructure flexibility, scalability and mobility, as well as more rapidly deployable, smaller footprint facilities in more locations.

That’s a tall order. But the answer to the first part, process and cleanroom flexibility, has been solved by a company called G-CON Manufacturing, innovators of POD technology. PODs are prefabricated, standard-size processing units (autonomous cleanrooms) built rapidly off-site, delivered and installed within a larger facility, and clustered together for efficient unit-to-unit processes that can ramp up or down to meet changing capacity requirements. In addition, PODs are also the ideal solution where regulations require independent process segregation and containment.

Swift erection of a larger, building shell structure (to contain the PODs) is the second issue, which prompted G-CON to join in a collaborative venture with Butler Manufacturing™, a global leader in design-build building systems, and Span Construction, a design-build General Contractor that’s one of the most prolific builders of steel structures in the world.

“In our industry, we’re seeing a paradigm shift away from capital intensive facilities to rapidly deployable and flexible infrastructures. Our collaboration with Butler and Span allows us to provide the total package of the processing spaces (PODs) and shell building structure,” said Maik Jornitz, CEO of G-CON.

Due to the fact that the larger Butler facility is primarily comprised of pre-engineered and tested roof and wall systems, these buildings are designed to fit together perfectly at the jobsite and be constructed at the same time the PODs are being built. This parallel-track construction compared to traditional, linear-track construction can reduce total erection timelines by as much as half while saving money and leading to production of needed therapeutics much faster.

Problem:

Pharmaceutical manufacturing infrastructures are often constructed consecutively — first the shell building, then utilities, followed by cleanroom structures, and then equipment installation. The sequential nature of the construction process only allows one activity at a time, which prolongs the overall time of construction, and accordingly, time to first product runs to up to 2 years.*

 

Solution:

A better alternative is building a manufacturing site in parallel. This means that the shell building, utility bundles, cleanroom infrastructures and process equipment are all built simultaneously, allowing the project to be completed much faster, from 6-8 months. Prefabricated cleanroom modules are manufactured off- site, factory acceptance tested there, and then shipped to the site and placed within a shell building…*

pod

 

There are more than two P’s in these PODs.

How will this POD revolution pay off for big pharma? Here are just some of the ways:

  • Process capacity – The true advantage is scalability – removing or adding PODs from or into the facility, so manufacturing process space can be turned on or off as needed, optimizing capacity flexing.
  • Profitability – By becoming operational sooner (saving up to a year or more in construction time) pharmaceutical manufacturers realize the benefits of the full product lifecycle.
  • Proximity – Smaller footprint buildings reduce construction schedules and allow production sites to be located closer to the markets they serve (in-country/for-country manufacturing).
  • Purpose – Or more specifically, re-purpose, since PODs can be disassembled and moved to another facility; converted to other processes, or sold. Shell buildings can also be re-purposed, rather than being mothballed or treated as an abandoned asset as they have been in the past.
  • Permitting – Because the FDA must approve manufacturing sites, cloning of such sites may abbreviate and expedite the approval process. With standard configuration PODs that are built with the same materials and under the same quality system, regulatory bodies will have to invest less time in understanding and qualifying the system.

The FDA’s 21st Century Initiative calls for maximally efficient, agile and flexible pharmaceutical manufacturing. The G-CON, Butler Manufacturing and Span Construction collaboration is poised to deliver such facilities in a way that no other company or collaboration has. It will be interesting to see if the industry heeds the call of the FDA and takes advantage of the products and expertise of these innovative companies.

To learn more, contact a Butler Corporate Accounts Manager. If you would like to schedule a meeting, please complete this simple form.

* Controlled Environments Magazine, How It Workshttp://www.cemag.us/articles/2015/05/how-it-works-prefabricated-cleanroom-podsspeed-installation-and-enable-repurposing

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