Good Manufacturing Practices (GMP) Facility
Launched in 2003, the GMP facility plays a critical role in moving promising discoveries from St. Jude laboratories into our clinics, ensuring that biopharmaceuticals and other biological products for patient use are manufactured in accordance with strict federal regulations.
OVERVIEW
St. Jude was the first pediatric cancer research center in the U.S. to open an on-site current Good Manufacturing Practice (GMP) facility. Launched in 2003, the GMP facility plays a critical role in moving promising discoveries from St. Jude laboratories into our clinics, ensuring that biopharmaceuticals and other biological products for patient use are manufactured in accordance with strict federal regulations.
IMPACT
The GMP facility provides St. Jude a key advantage: the ability to develop and produce innovative treatments for our patients that may not find an initial investment by a major pharmaceutical company. The wide-ranging expertise of GMP staff, coupled with the facility’s flexible design, allows rapid innovation to meet changing research needs. GMP staff are happy to work with investigators to develop new services as needed.
The GMP facility [is] key to our strategy of fast-tracking breakthroughs in basic research into products that we can bring through initial clinical trials. Any royalties from such products [are] put back into research that will help us develop more cures for childhood diseases.
Arthur Nienhuis, MD
Services and capabilities
The diverse products manufactured in the facility include novel vaccines, gene therapy products, monoclonal antibodies, recombinant proteins. Another major function of GMP staff is to work closely with St. Jude employees to prepare high-quality, cell-based products for bone marrow transplantation and cellular therapy procedures.
- Process development and scale-up services are provided by St. Jude Therapeutics Production and Quality (TPQ) staff.
- Manufacturing services are provided by the Children’s GMP, LLC, a company owned by St. Jude and located in the GMP facility.
The GMP pipeline
Step 1 ⬇
A St. Jude investigator identifies a biological agent with potential therapeutic applications
Step 2 ⬇
The agent’s therapeutic potential is supported by preclinical lab studies
Step 3⬇
The agent is transferred to the GMP, where staff develop and scale up manufacturing process and develop the analytical methods needed to support production.
Step 4⬇
Final product is manufactured, released, and delivered for use in the clinic
Director
Frank Fazio
President, Children’s GMP, LLC
Vice President, TPQ
frank.fazio@stjude.org