Deep in the heart of Texas

HOUSTON, Texas—Researchers at theUniversity of Texas MD Anderson Cancer Center and the Texas A&MUniversity System's new National Center for TherapeuticManufacturing (NCTM) recently announced they will partner up to wagewar against cancer. The prestigious MD Anderson center and soon-to-bebuilt massive research and teaching facility will share vastresources and a pool of knowledge toward developing cancer-fightingdrugs to patients at a faster pace than ever before.

The NCTM is the state of Texas' corebiological pharmaceutical manufacturing, research and educationfacility, now in construction on the Texas A&M University campusin College Station and scheduled for completion in December 2011.Once complete, researchers from both university systems will utilizethe NCTM's first-in-class resources to produce vaccines andtherapies for clinical use.

The agreement calls for MD Anderson tobecome a long-term partner and NCTM collaborator, thus increasing theability of lab researchers to quickly provide important new cancertreatments, including vaccines targeted to specific individuals. MDAnderson will invest $2.49 million in the NCTM and receive 5 percentof the new center's net margin, and Texas A&M System willreceive 5 percent of MD Anderson's equity position in spinoffcompanies that involve intellectual property related to NCTM. Amaster agreement governing intellectual property patenting andlicensing will be negotiated.

"As always, MD Anderson's goal isto eliminate cancer," says Dr. Raymond DuBois, provost andexecutive vice president at MD Anderson. "The NCTM—a unique,state-of the-art center—will allow the drugs we invent to bemanufactured more quickly, efficiently and inexpensively. That, inturn, will help us advance new therapies to clinical trials morerapidly."

The NCTM also will provide readilyavailable advanced manufacturing expertise at a level beyond thattypically found in cancer centers and academic medical and scientificprograms, he says.

"There won't be a focus on anysingle cancer type," DuBois says. "We expect this agreement tofocus on biologics—drugs that involve antibodies, vaccines,proteins. Our first several NCTM projects will probably involvevaccines invented at MD Anderson for a number of cancers. It isdifficult to imagine another partnership with the advancedmanufacturing capabilities of the NCTM or the combination of researchexpertise that MD Anderson and Texas A&M bring to thiscollaboration."

Both prestigious institutions willcollaborate on future grant and funding initiatives to advance cancerresearch.

"Scientific advances have put moreeffective, highly tailored therapies in reach for our cancerpatients, but the promise of individualized treatment also comes withmore complex research demands," DuBois says.

Michael D. McKinney, Texas A&MUniversity system chancellor, is also optimistic about what the twoinstitutions could do together.

The goal of the NCTM is to providerapid, cost-effective, FDA-compliant and scalable manufacturing thatwill enable an array of new products to enter clinical trials, saysDr. Michael Pishko, head of the Artie McFerrin Department of ChemicalEngineering at Texas A&M. The NCTM will initially focus ontherapeutics and vaccines for infectious diseases and cancer, as wellas maintaining broad capabilities across the spectrum of biologicaltherapeutics, including monoclonal antibodies, DNA and proteintherapeutics, subunit vaccines, and viral-based vaccines andtherapeutics, Pishko says. Particular emphasis will be placed on thedevelopment of standards and processes to enable transition ofpersonalized therapeutics, such as autologous cancer vaccines andtargeted nanoparticles, into wide-scale clinical use, he adds.

The NCTM will house two distinctfunctions—a GMP-compliant therapeutics production wing (focusing onproviding therapeutics and vaccines for clinical trials), and anacademic and administrative wing, Pishko says. The therapeuticsproduction wing will consist of approximately 105,000 square-feetthat will be segregated from the academic/administrative functionsvia controlled, secure access. The primary spaces contained in thetherapeutics production area will include an open bay area containingup to 20 pre-engineered, mobile, modular clean room pods to hostbioreactors, purification processes, and sterile vial fill; a qualitycontrol lab, a microbiology lab, shipping/receiving,refrigerated/cryo storage and waste decontamination; and a modularclean room pod "fit-up" area for final furnishing of new modules,along with an area for pod decontamination.

The academic and administrativefacility will consist of approximately 48,000 square-feet to includetwo teaching laboratories and adjoining cell culture laboratory; twoglass-enclosed GMP training suites to provide a "real-life"learning environment for students; two lecture auditoriums; acomputer lab; a large work-study hall; and numerous faculty andsponsor offices and workspaces.

"The facility will be the prototypefor a new generation of multi-product, multi-technology, flexiblepharmaceutical manufacturing facilities," Pishko says. "It willserve as a hub for research into biologics manufacturing, processoptimization and other disciplines."

The NCTM "will also serve as theoperational prototype for an anticipated international network ofmanufacturing research and development facilities that producerequired vaccines, antibodies and therapeutic proteins to protectagainst naturally emerging pathogens and intentional biologicalattacks," Pishko says. "Importantly, it will serve as thecornerstone for undergraduate and graduate training of futureprofessionals to lead this new biotechnology revolution."