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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.

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OVERVIEW

St. Jude opened the doors of children’s GMP manufacturing facility in 2003. The children’s GMP facility is accredited by the Foundation of the Accreditation of Cellular Therapy (FACT).

The St. Jude GMP facility has unparalleled product depth and breadth and provides St. Jude with the ability to develop, scale up, and manufacture innovative pediatric therapeutics quickly. The list of manufacturing capabilities included (CAR) T cells used in clinical trials for acute leukemias and solid tumors, modified stem cells to be used in treatment of hematological diseases, In-Vivo gene therapy products such as the adeno-associated viral vector (AAVs) used to treat Factor IX hemophilia, therapeutic proteins such as monoclonal antibodies (mAbs), and viral vaccines. The facility also manufactures some of the key complex reagents and raw materials used in many advanced therapeutics such as lentiviral vectors used in ex-vivo gene therapies and nucleases such as CAS9 protein used in gene editing applications. The GMP capabilities also include analytical assay development, full quality control release, and the execution of ICH standard stability studies.

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 plays a critical role in all our translational gene therapy and cell therapy efforts. For example, it was instrumental in developing our gene therapy approach to cure children with severe combined immunodeficiency. Likewise, it has generated all clinical grade vectors and cell products for our pediatric cancer immunotherapy program.

Stephen Gottschalk, MD, Chair, Department of Bone Marrow Transplantation & Cellular Therapy

Services and capabilities

30 processing and support rooms and International Standards Organization (ISO) 7- and ISO 5-rated cleanrooms.
Biosafety Level 3-approved laboratories
Process development and scale-up services provided by the Department of Therapeutics Production and Quality (TPQ)
Manufacturing services provided by the Children’s GMP, LLC (CGL), a St. Jude-owned LLC with separate staff that oversees cGMP Quality Assurance, Quality Control and cGMP Production.
Process and assay development
Analytical development
QC and materials management