Growth of new technologies like nanomaterials, bioinformatics, and latest biotech devices are reshaping the industry, and consequently, customers’ facilities requirements

From the advent of microscopic yet powerful “nanomaterials,” to growing applications of bioinformatics - roughly defined, the use of computers to analyze and solve biological problems, or, in lay terms, “genes on a chip” - technological advances have brought sweeping change to the biopharmaceutical industry in recent years.

Just as such changes are continually reshaping the way biopharm companies develop and deliver their products, in turn, their facilities’ needs have also remained fluid. DPR’s ability to adapt and change has kept it in the forefront of this evolving market, demonstrated by a long list of projects for clients that include Genentech, Chiron, Bayer, Roche, Immunex, Cell Genesys and IDEC Pharmaceuticals, to name just a few.

The focus on human genome-based research and product development-powered through the latest in computer and chip technology-has had a particularly strong impact on the facility requirements of biopharm companies in the 21st century. Many of their manufacturing facilities must now be designed and built not only to address the complex systems requirements relating to developing a biological-based product in a strictly controlled environment, but also to accommodate a different type of clean environment required for microelectronics or chip applications.

“What we’re seeing in this new technology is a hybrid of developing a building that is clean for microelectronics applications while also maintaining strict biological controls required for biopharm and biotech applications,” says Gavin Keith, who oversees much of DPR’s biopharm work in the Bay Area. “You have to incorporate systems designed to address both particulate controls and viral and bacterial controls. In addition, there are very specific protocols on how you turn over the systems and validate these facilities.”

Documenting and validating a cGMP-certified biopharm manufacturing facility with the FDA, the regulatory agency, is an exhaustive process that can take anywhere from six months to two years. It requires extensive documentation of how the systems were constructed down to the smallest detail, a process intended to ensure that the exact purity and consistency of drugs and products developed in the facility never varies over time.

A host of other challenges add to the complexity of biopharm projects. They include: increasingly fast-track construction schedules, often requiring complex sequencing and phased completion to facilitate the turnover and validation process; long lead time on key process equipment; extremely complex utility, HVAC and electrical systems requirements to maintain stringent environmental controls inside; a limited pool of qualified subcontractors; and a dynamic and extended design development process in which owners’ requirements often change in response to the rapidly changing market.