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.
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 diverse products manufactured in the facility include:
Although the process for each product is different, a typical path from the laboratory to the clinic might resemble this one:
As well as producing biopharmaceuticals discovered by researchers at St. Jude, GMP staff manufacture products that are discovered and developed by outside entities in collaboration with St. Jude faculty.
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. Visit our Human Applications Laboratory and Bone Marrow Transplantation pages to learn more.
Michael M. Meagher, PhD, is president of the Children’s GMP, LLC, and vice president of Therapeutics Production and Quality at St. Jude.