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ISCT Publications
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- Immuno-Gene Therapy Mini-Series on Supporting Externally Manufactured Cell and Gene Therapies
ISCT survey on hospital practices to support externally manufactured investigational cell-gene therapy products
CytotherapyVol. 24Issue 1p27–31Published online: November 19, 2021- Alexey Bersenev
- Michael P. Gustafson
- Patrick J. Hanley
Cited in Scopus: 3There is considerable interest in the next generation of personalized medicine, especially cell and gene therapy products such as chimeric antigen receptor T cells (CAR-Ts). Unlike other small molecules or pharmacologic drugs, most existing cell or cell-based gene therapy products (CGTs) require apheresis collection of the patient or donor, subsequent manufacture of the product, and final shipment of the product to the clinical site for infusion. Whereas traditional pharmaceutical drugs have involved the drug sponsor and the clinical site and clinical pharmacy, this new manufacturing paradigm has evolved, in many cases, to include an apheresis center, a cell processing lab, the sponsor's manufacturing facility, and a clinical site with or without a pharmacy. - Immuno-Gene Therapy Mini-Series on Supporting Externally Manufactured Cell and Gene Therapies
Delivering externally manufactured cell and gene therapy products to patients: perspectives from the academic center experience
CytotherapyVol. 24Issue 1p16–18Published online: November 6, 2021- Patrick J. Hanley
- Alexey Bersenev
- Michael P. Gustafson
Cited in Scopus: 1Cellular immunotherapy is the application of immune cells that are collected, and often modified ex vivo, to improve immune responses for a patient's treatment. The Foundation for the Accreditation of Cellular Therapy (FACT) defines immune effector cells (IECs) as cells designed to modulate immune responses for therapeutic purposes and includes cells such as T cells, B cells, natural killer (NK) cells and dendritic cells [1]. Many of these types of cells may be genetically modified to further enhance their cellular function.