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Deep in the heart of Texas
HOUSTON, Texas—Researchers at the University of Texas MD Anderson Cancer Center and the Texas A&M University System's new National Center for Therapeutic Manufacturing (NCTM) recently announced they will partner up to wage war against cancer. The prestigious MD Anderson center and soon-to-be built massive research and teaching facility will share vast resources and a pool of knowledge toward developing cancer-fighting drugs to patients at a faster pace than ever before.
The NCTM is the state of Texas' core biological pharmaceutical manufacturing, research and education facility, now in construction on the Texas A&M University campus in College Station and scheduled for completion in December 2011. Once complete, researchers from both university systems will utilize the NCTM's first-in-class resources to produce vaccines and therapies for clinical use.
The agreement calls for MD Anderson to become a long-term partner and NCTM collaborator, thus increasing the ability of lab researchers to quickly provide important new cancer treatments, including vaccines targeted to specific individuals. MD Anderson will invest $2.49 million in the NCTM and receive 5 percent of the new center's net margin, and Texas A&M System will receive 5 percent of MD Anderson's equity position in spinoff companies that involve intellectual property related to NCTM. A master agreement governing intellectual property patenting and licensing will be negotiated.
"As always, MD Anderson's goal is to eliminate cancer," says Dr. Raymond DuBois, provost and executive vice president at MD Anderson. "The NCTM—a unique, state-of the-art center—will allow the drugs we invent to be manufactured more quickly, efficiently and inexpensively. That, in turn, will help us advance new therapies to clinical trials more rapidly."
The NCTM also will provide readily available advanced manufacturing expertise at a level beyond that typically found in cancer centers and academic medical and scientific programs, he says.
"There won't be a focus on any single cancer type," DuBois says. "We expect this agreement to focus on biologics—drugs that involve antibodies, vaccines, proteins. Our first several NCTM projects will probably involve vaccines invented at MD Anderson for a number of cancers. It is difficult to imagine another partnership with the advanced manufacturing capabilities of the NCTM or the combination of research expertise that MD Anderson and Texas A&M bring to this collaboration."
Both prestigious institutions will collaborate on future grant and funding initiatives to advance cancer research.
"Scientific advances have put more effective, highly tailored therapies in reach for our cancer patients, but the promise of individualized treatment also comes with more complex research demands," DuBois says.
Michael D. McKinney, Texas A&M University system chancellor, is also optimistic about what the two institutions could do together.
The goal of the NCTM is to provide rapid, cost-effective, FDA-compliant and scalable manufacturing that will enable an array of new products to enter clinical trials, says Dr. Michael Pishko, head of the Artie McFerrin Department of Chemical Engineering at Texas A&M. The NCTM will initially focus on therapeutics and vaccines for infectious diseases and cancer, as well as maintaining broad capabilities across the spectrum of biological therapeutics, including monoclonal antibodies, DNA and protein therapeutics, subunit vaccines, and viral-based vaccines and therapeutics, Pishko says. Particular emphasis will be placed on the development of standards and processes to enable transition of personalized therapeutics, such as autologous cancer vaccines and targeted nanoparticles, into wide-scale clinical use, he adds.
The NCTM will house two distinct functions—a GMP-compliant therapeutics production wing (focusing on providing therapeutics and vaccines for clinical trials), and an academic and administrative wing, Pishko says. The therapeutics production wing will consist of approximately 105,000 square-feet that will be segregated from the academic/administrative functions via controlled, secure access. The primary spaces contained in the therapeutics production area will include an open bay area containing up to 20 pre-engineered, mobile, modular clean room pods to host bioreactors, purification processes, and sterile vial fill; a quality control lab, a microbiology lab, shipping/receiving, refrigerated/cryo storage and waste decontamination; and a modular clean room pod "fit-up" area for final furnishing of new modules, along with an area for pod decontamination.
The academic and administrative facility will consist of approximately 48,000 square- feet to include two teaching laboratories and adjoining cell culture laboratory; two glass-enclosed GMP training suites to provide a "real-life" learning environment for students; two lecture auditoriums; a computer lab; a large work-study hall; and numerous faculty and sponsor offices and workspaces.
"The facility will be the prototype for a new generation of multi-product, multi-technology, flexible pharmaceutical manufacturing facilities," Pishko says. "It will serve as a hub for research into biologics manufacturing, process optimization and other disciplines."
The NCTM "will also serve as the operational prototype for an anticipated international network of manufacturing research and development facilities that produce required vaccines, antibodies and therapeutic proteins to protect against naturally emerging pathogens and intentional biological attacks," Pishko says. "Importantly, it will serve as the cornerstone for undergraduate and graduate training of future professionals to lead this new biotechnology revolution."