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Feature Articles : May 1, 2008 ( )
Versatility Concerns Impact Facility Design
Current Trends Favor Smaller, Less Capital-Intensive Manufacturing Operations!--h2>
Among the uncertainties in biotechnology, constructing a new facility is perhaps the riskiest venture of all. Plants must be constructed in anticipation of, rather than in response to, a product’s success. As a consequence, developers of biological products are hedging their bets by adopting strategies in which design, building, and qualification overlap. Because a plant’s ultimate purpose may not be known until after the ribbon-cutting, owners are also designing in more flexibility than they might have a decade ago.
These days, construction and renovation are as likely to be driven by market and technology forces as by general capacity needs. “With biotech, large capital projects are particularly risky as their planning must begin long before a product’s anticipated approval,” says Gary Nagamori, managing director at architecture and engineering firm CUH2A. “The probability that a company will use a product for its intended function is small, so big facilities represent high risk.”
Trends that are changing biotech facility design and construction include outsourcing, the growing use of disposable process equipment, improvements in protein titers and yield, and emerging patient-specific or personalized treatments.
Designing around disposable equipment confers a level of versatility that was unavailable for facilities designed 10 or 15 years ago. Personalized medicine and high titers, in particular, have rendered moot the capacity-crunch concerns of the early 2000s. Smaller batches, in turn, provide greater flexibility and responsiveness to other market forces.
“In this scenario architects and engineers are tasked with designing out risk while satisfying the demand for collaboration and interoperability,” Nagamori says. “Risk, therefore, becomes a design driver.”
One countertrend is the ongoing shortage of skilled labor, which means companies are always training new workers. So paradoxically, as processes become more efficient and adaptable, companies must factor in 30–40% more room for technicians and scientists in training.
More Complex than Commercial Space
While commercial/educational facilities devote approximately 20% of resources to mechanical, electrical, plumbing, air handling, and heating and cooling utilities, biotech facilities must factor these critical components at 50–60% of total construction costs. “Commercial systems may just have hot and cold water,” observes John Planz, project executive at Suffolk Construction. “A research lab or manufacturing facility has those, plus systems for purified water, distilled water, and perhaps even reverse osmosis.”
Managing and Scheduling Big Projects
MannKind is completing a facility in Danbury, CT, where it hopes to manufacture its Phase III inhaled insulin product, Technosphere® Insulin.
Built on Flexibility
Bayer Healthcare began construction of a new clinical manufacturing facility at its Berkeley, California campus two years ago and received a Certificate of Occupancy in June 2006. Building 66, as the plant is known, consists of four environmentally controlled zones for inoculum preparation, fermentation/isolation, and two purification suites.
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