Thursday, July 9, 2009

GMP - a perfect fit for Aggieland

The National Center for Therapeutics Manufacturing has been the target of some potbanger criticisms. Some of this is based on a tempest in a teapot stirred up by our Governor's critics.
Although the fund's normal procedures were largely followed, a small legislative firestorm has broken out because of several factors: Texas A&M is Perry's alma mater. The grant was five times as large as any other given from the fund. The money was transferred from another economic development fund with a different purpose. And an advisory board that usually votes on such projects did not in this case.
But as we know, the ends justify the means, and the ends here were described by two of our fearless System leaders
“We’re creating a prototype that is absolutely critical for improving the nation’s ability to develop new vaccines and therapeutics in an accelerated and cost-effective manner. It will be especially important in the larger goal of protecting our citizens from the threat of bioterror weapons such as anthrax and Ebola virus,” Giroir said.

“This Center sets a national standard for aligning the strengths of academic research and commercial application for a broad-ranged public benefit,” said Diedrich. “The system has been at the forefront of creating marketplace models of innovative collaborations that show the tremendous power of technology to dramatically reshape the economy and our lives. Those efforts come together in this world-class facility.”
The key to this is the ability to make biological therapeutics and vaccines under Good Manufacturing Practice (GMP) methods. Nature Bioentrepreneur examined GMP facilities at universities in 2003:
But regulatory officials should hold university facilities to the same standards as industry manufacturers, particularly when a product nears human testing, says Nadine Ritter, an independent Biotechnology Product consultant based in Washington, DC. "University labs want to do things cheaper and faster and that's fine—until the product goes into a patient," Ritter adds, cautioning that universities are not scrutinized as rigidly as industry.
Here at Texas A&M we expect to be scrutinized as rigidly as any industry, building on our experience with the CDC.
Jim Cahill, a regulatory analyst who assesses industrial laboratories for Cato Research Institute (Philadelphia, PA, USA), agrees that universities face barriers to securing GMP status because "GMPs are designed to ensure that researchers do things over and over in exactly the same way," says Cahill, "but universities are designed to make people think."
This is what makes Texas A&M ideal for GMP. We do things over and over in exactly the same way and call it Tradition.

No comments:

Post a Comment