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Next month St. Jude Children's Research Hospital will become the only pediatric cancer research center in the United States to open a Good Manufacturing Practices (GMP) facility for producing vaccines, drugs, proteins, gene-based molecules and other biological products. The facility also has Biological Safety Level (BSL) 3 laboratories to accommodate work with microorganisms that must be specially contained.
The GMP facility, which meets standards of operation established by the U.S. Food and Drug Administration (FDA), will allow the internationally renowned research center to produce such products as the three-tiered AIDS vaccine currently under development at St. Jude, as well as a cholera virus, vaccines for influenza and parainfluenza, immunotherapy proteins and other drugs and diagnostic products.
The facility is designed to support the hospital’s goal of swiftly taking research from the laboratory to the clinic. The GMP facility’s mission is to solve the problem of how to engage major pharmaceutical companies that are reluctant to make a large up-front investment in developing products that will have a limited market.
“The GMP facility will be key to our strategy of fast-tracking breakthroughs in basic research into products that we can bring through initial clinical trials,” said Arthur Nienhuis, M.D., hospital director. “Pharmaceutical companies can then take these vaccines and drugs through final development and bring them to market so children can benefit from them. Any royalties from such products would be put back into research that will help us develop more cures for childhood diseases.”
The facility has a modular design that allows it to adapt quickly to new demands as ongoing research leads St. Jude scientists in productive new directions. Rather than being restricted to a static design, research and development laboratories in the GMP can be modified and reassigned to accommodate new projects.
The facility also reflects the fact that research in the molecular biology of catastrophic pediatric diseases such as leukemia and brain cancer occurs largely in academic research institutes, Nienhuis says. Thus, the opening of the GMP facility at St. Jude, which is one of the leading institutes conducting such basic research, ensures that promising therapies will not be abandoned for lack of an initial commitment from a major pharmaceutical company.
St. Jude Children’s Research Hospital
St. Jude Children’s Research Hospital, in Memphis, Tennessee, was founded by the late entertainer Danny Thomas. The hospital is an internationally recognized biomedical research center dedicated to finding cures for catastrophic childhood diseases. The hospital’s work is supported through funds raised by ALSAC. ALSAC covers all costs not covered by insurance for medical treatment rendered at St. Jude. Families without insurance are never asked to pay.
Last update: April 2003