University of Pittsburgh Medical Center in lead for high-tech vaccine factory
Allison M. Heinrichs
Pittsburgh Tribune-Review
Aug 25, 2009
The University of Pittsburgh Medical Center is the front-runner for a potential $830 million public-private vaccine development and manufacturing facility the federal government largely would pay for, officials said Friday at a congressional hearing Downtown.
Several locations in Western Pennsylvania are being evaluated for the facility, which could add 1,000 employees to UPMC's payroll. But a spot near the old Pittsburgh airport in Moon is the most attractive location for such a sensitive operation because of its proximity to resources such as the National Guard, said UPMC President and CEO Jeffrey Romoff.
Romoff testified at the hearing called by Democratic Sen. Arlen Specter of Philadelphia, who is seeking ways to better prepare for bioterrorism attacks and emerging infectious diseases, such the H1N1 virus known as swine flu.
The government is considering options to improve its vaccine production capacity, including a vaccine factory, and set aside more than $12 billion to address the issue. If such a factory were found to be the best option, the government would seek competitive bids, Specter said.
"If we are able to, through competitive bidding, land this public-private partnership, with your assistance, here in Pittsburgh, I have no doubt that we'll be able to attract ... other private biotechnology companies to come to Pittsburgh and set up laboratories here," Romoff said.
As many as 70,000 jobs could be created as an indirect result of a UPMC vaccine factory, he said.
Jeffrey Romoff, far left, President and CEO of the University of Pittsburgh Medical Center, testifies at a congressional hearing in U.S. District Court in Pittsburgh Friday, August 21, 2009, about his views on vaccine production capacity and whether the U.S. is prepared. He joined a panel with four distinguished doctors. Heidi Murrin/Tribune-Review
The factory would be built to enable researchers, under normal operation, to work on vaccines for several diseases in perhaps eight suites, said Bob Cindrich, UPMC chief legal officer. If an emergency occurred, such as a release of anthrax, every suite would be diverted to making anthrax vaccines in "surge production," he said.
"In industry, the standard way of going about making vaccines is that every vaccine has its own facility," said Dr. Donald Burke, dean of the University of Pittsburgh Graduate School of Public Health and director of Pitt's Center for Vaccine Research. "When a pharmaceutical company is planning to market a new vaccine, they build an entire facility with technology designed around that vaccine.
"Our proposal is a flexible methodology that allows us to make a new vaccine quickly, without having to build a new plant," said Burke, who testified at the hearing.
The UPMC vaccine factory could quickly change its production by using a disposable plastic technology developed by GE Healthcare, said Nigel Darby, vice president for BioTechnologies at GE.
In a traditional vaccine factory, stainless steel equipment needs extensive cleaning and testing after any contamination, or if it is switched to making a different vaccine, which is time-consuming and costly, Darby testified.
"We found that allowing us to replace the traditional stainless steel manufacturing technology with disposable plastic technology allows us to rapidly reconfigure the manufacturing process using off-the-shelf, ready-to-use components," he said.
"After manufacturing, the components are simply discarded and ... expensive cleaning and biodecontamination processes required at traditional facilities are significantly reduced, improving the facility productivity substantially but maintaining the overall level of safety," he said.
Dr. Bruce Gellin, director of the Department of Health and Human Services' National Vaccine Program Office, said he found UPMC's proposal "impressive" but declined to say it is the best way to address the country's vaccine manufacturing capacity problem. He testified he is unaware of other proposals as advanced as UPMC's.
At least four other institutions have identified themselves as potential locations for such a government-sponsored factory, Specter said. He declined to name the institutions but said one is in Texas and another is in North Dakota.
"UPMC has jumped ahead," Specter said. "We've already had meetings with the vice president, the secretary of Health and Human Services, and Homeland Security."
Romoff met with Vice President Joe Biden in March, Health and Human Services Secretary Kathleen Sebelius in May and Homeland Security Secretary Janet Napolitano in June to discuss the facility. UPMC invested $20 million into preparing for the facility, Romoff said.
UPMC would need a $580 million government investment to design, build and begin operation. The health care giant would then come up with the remaining $200 million to $300 million by contributing a large portion itself, getting grants from private foundations and investments from private companies, such as GE Healthcare, Romoff said.
"When it comes to the protection of the national security from a bioterroristic attack ... this country and virtually all countries in the world are relatively defenseless," Romoff said. "This is a very, very grave problem and one that we don't often realize, regrettably, until after the fact."
