Simplified protocol for clinical-grade tumor-infiltrating lymphocyte manufacturing with use of the Wave bioreactor

TY - JOUR

T1 - Simplified protocol for clinical-grade tumor-infiltrating lymphocyte manufacturing with use of the Wave bioreactor

AU - Donia, Marco

AU - Larsen, Signe Møllebæk

AU - Met, Ozcan

AU - Svane, Inge Marie

N1 - Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

PY - 2014/8

Y1 - 2014/8

N2 - BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs).METHODS: To ensure higher applicability of TIL production to laboratory routine, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution.RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL products, which mediated clinical regression in patients with metastatic melanoma.CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment.

AB - BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs).METHODS: To ensure higher applicability of TIL production to laboratory routine, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution.RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL products, which mediated clinical regression in patients with metastatic melanoma.CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment.

KW - Bioreactors

KW - CD8-Positive T-Lymphocytes

KW - Cell Proliferation

KW - Cell- and Tissue-Based Therapy

KW - Humans

KW - Immunotherapy, Adoptive

KW - Lymphocytes, Tumor-Infiltrating

KW - Melanoma

KW - Neoplasm Metastasis

U2 - 10.1016/j.jcyt.2014.02.004

DO - 10.1016/j.jcyt.2014.02.004

M3 - Journal article

C2 - 24831841

SN - 1465-3249

VL - 16

SP - 1117

EP - 1120

JO - Cytotherapy

JF - Cytotherapy

IS - 8

ER -