Pharma Facilities: Can One Patent Agility?

Two years ago, Joseph Lam, managing director of Beacons Pharmaceuticals Ltd., a leading generics manufacturer in Singapore, was awarded a U.S. patent for a novel drug facility layout (click here to view the patent, and here for a detailed summary of the layout). Mention of this provoked some surprise from experts in the U.S. engineering and construction world. They had never heard of a plant layout, however creative, being patented.

Lam developed his system, the Satellite Process Assurance Hub (SPAH), in response to what he saw as deficiencies in the design of pharma plants. It has been under development for at least the last eight years, he says. “Just as PAT will take time to be realized, so has this,” he says.

Somewhat similar to some “hub and spoke” layouts found in the petrochemicals industry, and incorporating tenets of “design for Lean” that more companies are including in new facilities, the layout provides for a central viewing area. As Lam explained at the ACHEMA conference last summer, the layout divides into three geographical zones. Materials handling and production operations are wrapped around a central spine, which forms a hub in the production zone, provides access for people, contains the QC lab, and also provides more access to people at Level 2.

SPAH has a number of engineering and vendor partners, including Foster Wheeler, Glatt, and ABB, and, Lam says, preliminary engineering cost data suggests that use of SPAH can reduce overall area by 20%, and cost $3000-$5000 per square meter to construct.  Commercialization is set for 2011-2012, Lam says.

SPAH is characterized to be opened and flexible for integration with all types of technology including modular systems, and the company is actively pursuing licensees.  Based on Foster Wheeler’s conservative estimates, Lam says, using SPAH would allow savings of at least 20%, not only per project, but also in the entire plant life cycle.

Originally developed for tableting plants, Lam says the technology may best be used for biotech applications.