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Finding Cures. Saving Children.
Current Good Manufacturing Processes (cGMP) Facility
The GMP Facility at St. Jude
St. Jude seeks to find cures for catastrophic childhood diseases and develop better ways to treat them. In April 2003, St. Jude unveiled a dramatic testament to that determination to find cures and save children: the Good Manufacturing Practices (GMP) facility at St. Jude.
St. Jude is one of the few pediatric cancer research centers that has built such an on-site facility. The GMP has a core unit dedicated to producing highly specialized medicines and vaccines under government-approved Good Manufacturing Practices guidelines. This facility lets St. Jude pursue research and development projects that pharmaceutical companies are reluctant to attempt because of investor demands for profitable products.
The GMP is a dynamic, 21st century biomedical workshop for making vaccines, drugs, proteins, gene-based molecules, and other biological products. The facility also has Biological Safety Level (BSL) 3 laboratories that will accommodate work with microorganisms that must be specially contained.
The facility’s modular design allows it to quickly adapt to new demands as ongoing research discoveries lead St. Jude scientists in productive new directions. This ability to adapt laboratories and manufacturing facilities to changing needs makes the GMP a long-term medical research commitment to the children of the world. It also supports the hallmark strategy of St. Jude: swiftly taking research from the laboratory to the clinic. This strategy continues to pay great dividends to children treated at St. Jude as well as those children around the world whose doctors continue to look to St. Jude for new and improved therapies.
Most important, the facility will let St. Jude develop products in accordance with the federal government’s Good Manufacturing Practices regulation-a vital advantage to ensuring the timely transfer of research breakthroughs to young patients. The St. Jude strategy does not include the issue of potential profits, which are needed to attract the interest of the pharmaceutical industry. Thus, this self-sufficiency ensures that St. Jude researchers will be able to fast-track production of new investigational vaccines and other medicines.
The GMP will be a powerful research tool that will help St. Jude maintain its preeminent position among pediatric research facilities worldwide.
As of January 01, 2006, St. Jude has leased some of the space in this facility to the Children's GMP, LLC. St. Jude will continue product development activities in the facility while transferring the responsibilities for the actual production of clinical products to this new company. The company will only produce clinical materials for St. Jude and collaborating centers.
