FORT COLLINS – It has been said that a sign of wisdom is realizing what you don’t know and seeking the counsel of those who do.

By that measure, Colorado State University has made a wise decision to hire an outside firm with experience in the pharmaceutical industry to run the manufacturing facility associated with its new Research Innovation Center.

In the first such agreement, CSU has awarded the contract for operation of its new manufacturing facility to Pinnacle Biopharma LLC. Fort Collins-based startup Pinnacle will operate as a contract manufacturing organization, providing Chemistry Manufacturing and Controls, or CMC, development services to commercial clients as well as new enterprises developing at the RIC and other Colorado research institutions.

The 72,000-square-foot, $53 million center on the Foothills Campus west of Fort Collins allows university and private researchers to work together in state-of-the-art bioscience laboratories to test, manufacture and gain approval for vaccines and treatments for some of the world’s most deadly diseases. Pinnacle’s role will be in the areas of compliance with the U.S. Food and Drug Administration’s Good Manufacturing Practices, process development and pharmaceutical development, including formulations, stability research and analytical methods.

In the shadow of the sleek, new RIC with its dramatic views of the foothills, the inconspicuous GMP facility behind it could be overlooked. But it is in this low-profile building that important work will be done.

“We surveyed what was available here and across the country in terms of GMP manufacturing and it became immediately clear there was a need for this type of facility,´ said Bill Farland, vice president for research at CSU.

Features like having utility space available above the clean rooms, so the sterility of the work space won’t be compromised every time a light bulb needs to be changed, make the facility attractive to companies needing manufacturing space that meets high-level specifications.

“This facility allows companies to scale up from the bench to clinical trials without having to go through the arduous process of validation,´ said Anthony Pilkington, Pinnacle’s COO. “The validated equipment is ready for them. We can provide the stability in the controlled conditions they need.”

There is currently no contract aseptic fill-finish (a process that allows for the sterile filling of drug products into their final containers) organization in Colorado. The CSU manufacturing facility can handle everything from clinical trials to small-scale commercial production of 10,000-dose batches.

Construction of the GMP facility is finishing up this month, with certain CMC development activities possibly beginning as early as the first quarter of next year. Aseptic manufacturing is expected to commence in the third quarter of 2011 after installation and validation of specialized pharmaceutical equipment.

Part of bioscience supercluster

The operation agreement with Pinnacle is an extension of CSU’s supercluster model for public-private partnerships and technology transfer. The multidisciplinary structure focuses on enabling research to move to market more quickly by mirroring real-world business practices. The RIC is part of the bioscience supercluster.

The supercluster enterprises are governed by CSU Ventures, a not-for-profit corporation that serves as a business-development ally for the academic researchers and is a subsidiary corporation of the Colorado State University Research Foundation.

“The supercluster concept is based on the idea that there are areas at the University that have a critical mass of faculty within them, areas where developing intellectual property is part of daily business,” Farland said. “Our sense was that if we could help to foster interactions among individuals at the university and in the private sector at the early stages of development we could accelerate the pipeline to more quickly get the benefits of our research to society.”

In the past, researchers didn’t have a clear-cut path to get their bioscience breakthroughs out to the people they could help.

“It was a case of tossing something over the transom and hoping somebody would pick it up,” Farland said. “They call this gap between discovery and getting something to market the ‘Valley of Death.’ By leasing the GMP facility to a company both with experience and an interest in the facility as a business proposition we hope to help build the biomedical capabilities of Northern Colorado.”

That’s where Pinnacle comes in.

“While they produce great science, university researchers are sometime oblivious about the requirements of commercial product development,´ said Pinnacle CEO Patrick Bols. “We at Pinnacle grew up in this world and hope to contribute not only by clarifying the requirements, but also by advancing their work by performing services for them that meet all those extra requirements.”

While the upfront agreement between CSU and Pinnacle is unique, there have been other universities who started out in GMP manufacturing and then gradually became more commercially oriented, including the Waisman Clinical Biomanufacturing facility at the University of Wisconsin-Madison. As the CSU facility will be, the Waisman clean-room facility is equipped with staff and equipment necessary for GMP manufacturing to serve researchers as they enter early development of new therapies and advance those therapies into human clinical trials.

“We believe that CSU has gotten it right,” Bols said. “The efforts taking place at CSU will ultimately result in a productive cluster of companies related to the bio-tech industry. Some will develop therapeutic products, vaccines or medical devices, while others will assist those developing companies by providing much needed services.”