PRESS RELEASES   Planning is key for drugmaker 04/02/2008 Wed April 2, 2008 Jim Stafford Business Writer, The Oklahoman Dr. William Canfield escorted a group of visitors through the Cytovance Biologics manufacturing plant this week, but not before handing out disposable white “gowns,” hairnets and booties. Cytovance Biologics began operations in the Presbyterian Health Foundation Research Park in 2007 and is a contract drug manufacturer for pharmaceutical firms and medical researchers. Canfield is the company's chairman of the board. To meet regulatory requirements for manufacturing biological products used in human clinical trials, the $20 million facility must be kept virtually free of any impurities, Canfield said before opening the door to a special airtight hallway as he escorted the group inside. “This is actually a very light level of gowns compared to what we use in the (laboratory) rooms,” said Darren Head, the company's new president and chief executive who accompanied the group on the tour. “You are talking about full bunny suits for those areas.” Head became the company's chief executive about three weeks ago, coming to Oklahoma City from Atlanta, where he was vice president of operations for the publicly traded pharmaceutical company, Immucor Inc. “We're in what we call the ‘dirty corridor,'” Canfield said as the group walked into a brightly lit long hallway that could easily pass a white-glove inspection. Visitors could peer into laboratories filled with equipment used in the process to grow cells and produce proteins for use in clinical trials. Staying ahead of expectations The Cytovance plant was built to exacting specifications so that drugs can be developed in its labs under what is known as “current good manufacturing practices.” The standards required a long validation process after the facility was completed. It still requires continuous documentation of virtually every process and piece of equipment used in the plant. Everything from the purity of the air and water to the accuracy of scales must be tested and retested over an extended time to ensure the integrity of the process, Canfield said. No impurities can be introduced into the atmosphere. For example, employees enter the laboratory areas through a locker room where they put on special gowns. They can only enter from one direction. There are no door handles on the outside of the laboratory areas to allow someone to re-enter. Once workers exit the laboratory, they have to leave through the “dirty corridor,” and if they want to re-enter, they must put on new scrubs and gowns. Canfield's commentary focused on the exhausting requirements that must be met for such a facility to provide FDA-approved manufacturing for drugs that eventually will be used in human clinical trials. “You have to prove that every pipe, every wire, every communication starts where it is supposed to and goes to the other end and has no breaks,” Canfield said. “That takes a long time. You have to come up with a plan for how to do it, and then you have to execute it.” Planning takes longer than production The time spent preparing the facility and the reactors compared with that of actually producing the proteins needed for new drug trials is about “10 or 20 to 1,” Canfield said. “This is all about getting ready to do it, and then it's actually very simple to do,” he said. In fact, the actual laboratories that house the reactors that produce new proteins for clients fill only about 10 percent or so of the 44,000-square-foot building. Offices and the massive number of pipes for heating, air and ventilation take up the vast majority of the space. Head, who worked at Immucor for about eight years, called the validation process the “the cost of doing it right the first time. It's a lot cheaper in the long run to go ahead and build all the engineering in up front instead of always being constantly at the edge of what is required.” Although some former business partners founded Cytovance and started construction of the plant in 2004, Canfield did not get involved as an investor in the project until a key investor, John Crowley, dropped out in 2005. Canfield, who founded and was chief scientific officer for Novazyme Pharmaceuticals, which was bought out by Genzyme for more than $200 million in 2001, stepped up with other Oklahoma City investors with $9 million to rescue Cytovance from near bankruptcy. Company has five clients Today Cytovance offers a gleaming, state-of-the-art facility to pharmaceutical companies and medical researchers who want specific quantities of new drugs for clinical trials. The company has production contracts with about five clients, he said. “The success of Cytovance is already apparent, noted by the number and significance of contracts for biologics manufacturing it has attained and completed,” said Michael Anderson, president of the Presbyterian Health Foundation, which also invested in the project after Crowley dropped out. “Dr. Canfield has developed an outstanding staff. The new leadership of Darren Head, and the continued expertise of Steven Perry, vice president and manager of operations, assures good science, product development and noteworthiness for the future.” Cytovance employs 38 people and expects to have 40 by the end of the year and another 20 percent in 2009, Canfield said. “We're trying to hire as many local people as we can, but for the high-skilled positions, there is no one doing this work here,” he said. The tour ended when Canfield escorted the group back down the corridor and to an outer room to shed their gowns. The air flow would wash all the impurities the party carried into the corridor back to less sterile environments on the outside. At Cytovance Biologics, it's a one-way street. “You can't go from a dirty area back to a clean area,” Canfield said, tossing the disposable gowns into a waiting trash bin. Jim Stafford: 475-3310, jstafford@oklahoman.com