Biopharmaceutical production: Turning laboratory discoveries into life-saving treatments
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:
- Novel vaccines
- Gene therapy products
- Monoclonal antibodies
- Recombinant proteins
From discovery to biological product
Although the process for each product is different, a typical path from the laboratory to the clinic might resemble this one:
- A promising biological agent (a potential treatment) is discovered in a St. Jude research laboratory.
- The agent’s therapeutic potential is supported by preclinical laboratory studies.
- Phase I/II clinical studies are planned to assess how humans tolerate the agent and whether it offers therapeutic benefit for a specific disease.
- The agent is transferred to the GMP facility, where St. Jude staff develop and scale up a manufacturing process and develop the analytical methods needed to support production. This complex process ensures that a high-quality product can be made in sufficient amounts for the planned studies.
- The final product is manufactured, released and delivered for use in the clinic by Children’s GMP, LLC, a company owned by St. Jude and located in the same facility used for development activities.
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.
Bone marrow transplantation and cellular therapy
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.