Details

Autor(en) / Beteiligte

• De Santis, Gil Cunha
• Langhi Junior, Dante Mário
• Feitoza, Andreza
• Mendrone Junior, Alfredo
• Kutner, José Mauro
• Covas, Dimas Tadeu
• Couto, Samuel Campanelli Freitas
• Guerino-Cunha, Renato L.
• Orellana, Maristela Delgado
• Rizzo, Sílvia Renata Cornelio Parolin

Titel

Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control

Ist Teil von

• Hematology, Transfusion and Cell Therapy, 2021-11, Vol.43 (Suppl 2), p.S35-S41

Ort / Verlag

Elsevier España, S.L.U

Erscheinungsjahr

2021

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Chimeric antigen receptor T cells (CAR-T), especially against CD19 marker, present in lymphomas and acute B leukemia, enabled a revolution in the treatment of hematologic neoplastic diseases. The manufacture of CAR-T cells requires the adoption of GMP-compatible methods and it demands the collection of mononuclear cells from the patient (or from the donor), generally through the apheresis procedure, T cell selection, activation, transduction and expansion ex vivo, and finally storage, usually cryopreserved, until the moment of their use. An important aspect is the quality control testing of the final product, for example, the characterization of its identity and purity, tests to detect any contamination by microorganisms (bacteria, fungi, and mycoplasma) and its potency. The product thawing and intravenous infusion do not differ much from what is established for the hematopoietic progenitor cell product. After infusion, it is important to check for the presence and concentration of CAR-T cells in the patient's peripheral blood, as well as to monitor their clinical impact, for instance, the occurrence of short-term, such as cytokine release syndrome and neurological complications, and long-term complications, which require patient follow-up for many years.