The Marcus Center for Cellular Therapy facilitates the manufacturing and delivery of cell and gene therapies, which are some of the most novel treatments available to patients with diseases resistant to standard care protocols. The state-of-the-art, good manufacturing practice (GMP)-compliant lab is anticipated to shorten wait times for cell and gene therapy by allowing patients to receive these therapies in-house at Arthur M. Blank Hospital. The on-site lab also aims to expedite Children’s-led research examining new uses for cellular and gene therapy, allowing researchers to bring therapies to the bedside more quickly. The center is one of the only pediatric GMP labs in the country offering cell and gene therapy for patients with a variety of diseases and conditions beyond just cancer.

The Marcus Center for Cellular Therapy is registered for accreditation with the Foundation for the Accreditation of Cellular Therapy and will receive this designation after one year of operations. The center meets the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals established by the U.S. Food and Drug Administration, which ensure proper design, monitoring and control of manufacturing processes and facilities. The center features:

• Four ISO 7 manufacturing clean rooms
• GMP analytical laboratory for quality control testing
• Cryogenic storage facility
• Quarantined good storage area
• Sample processing area
• Released goods storage area
• Closed bioreactor systems

We are examining several uses for cell and gene therapy, currently planning or conducting clinical trials investigating treatments for the following diseases, with more to come.

• Dilated cardiomyopathy
• Graft-versus-host disease 
• High-risk leukemia and lymphoma 
• Hypoplastic left heart syndrome
• Neuroblastoma
• Osteogenesis imperfecta
• Sickle cell disease

The Marcus Center for Cellular Therapy allows Children’s researchers to pursue their cellular and gene therapy ideas without having to take them off-site for manufacturing. The center is also working to collaborate with other sites across the country to deliver treatment options not only in Atlanta, but through a variety of sites around the nation. Capabilities include:

• New product development
• Pre-clinical scale-up
• Quality control testing
• Process validation
• Cell collection
• Cryo-storage of cells, call banks and drug products
• Manufacturing master cell banks and working cell banks for off-the-shelf cell therapies
• Cell therapy product manufacturing for:
• Mesenchymal stromal cells
• Dendritic cells
• Engineered T-cell receptor
• Chimeric antigen receptor T-cells
• Gamma delta T-cells
• Tumor infiltrating lymphocytes

• Doug Graham, MD, PhD, Chief, Aflac Cancer and Blood Disorders Center
• Muna Qayed, MD, Medical Director, Marcus Center for Cellular Therapy
• Trent Spencer, PhD, Research Director, Marcus Center for Cellular Therapy
• Ana Marie Landin, PhD, GMP Technical Director, Marcus Center for Cellular Therapy