Expanding access to CAR T cell therapies through local manufacturing

Expanding access to CAR T cell therapies through local manufacturing

Schuster, S. J. et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N. Engl. J. Med.380, 45–56 (2019).

Article 
CAS 
PubMed 

Google Scholar 

Grupp, S. A., DiNofia, A. M. & Si Lim, S. J. Tisagenlecleucel for treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia. Pediatr.BloodCancer68, e29123 (2021).

Google Scholar 

Neelapu, S. S. et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N. Engl. J. Med.377, 2531–2544 (2017).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Abramson, J. S. et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet396, 839–852 (2020).

Article 
PubMed 

Google Scholar 

Brentjens, R. J. et al. Eradication of systemic B-cell tumors by genetically targeted human T lymphocytes co-stimulated by CD80 and interleukin-15. Nat. Med.9, 279–286 (2003).

Article 
CAS 
PubMed 

Google Scholar 

Kalos, M. et al. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci. Transl. Med.3, 95ra73 (2011).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Larson, R. C. & Maus, M. V. Recent advances and discoveries in the mechanisms and functions of CAR T cells. Nat. Rev. Cancer21, 145–161 (2021).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

June, C. H., O’Connor, R. S., Kawalekar, O. U., Ghassemi, S. & Milone, M. C. CAR T cell immunotherapy for human cancer. Science359, 1361–1365 (2018).

Article 
CAS 
PubMed 

Google Scholar 

Finck, A. V., Blanchard, T., Roselle, C. P., Golinelli, G. & June, C. H. Engineered cellular immunotherapies in cancer and beyond. Nat. Med.28, 678–689 (2022).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Lowery, F. J. et al. Molecular signatures of antitumor neoantigen-reactive T cells from metastatic human cancers. Science375, 877–884 (2022).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Liu, E. et al. Use of CAR-transduced natural killer cells in CD19-positive lymphoid tumors. N. Engl. J. Med.382, 545–553 (2020).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Rohaan, M. W. et al. Tumor-infiltrating lymphocyte therapy or ipilimumab in advanced melanoma. N. Engl. J. Med.387, 2113–2125 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Center for Biologics Evaluation and Research (CBER). Approval Letter—Kymriah. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/106989/download (2017).

Center for Biologics Evaluation and Research (CBER). Approval Letter—Yescarta. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/108458/download (2017).

Center for Biologics Evaluation and Research (CBER). Approval Letter—Tecartus. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/140415/download (2020).

Center for Biologics Evaluation and Research (CBER). Approval Letter—Breyanzi. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/145712/download (2021).

Center for Biologics Evaluation and Research (CBER). Approval Letter—CARVYKTI. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/156572/download (2022).

Center for Biologics Evaluation and Research (CBER). Approval Letter—ABECMA. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/147062/download (2021).

Center for Biologics Evaluation and Research (CBER). Approval Letter—Breyanzi. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/159473/download (2022).

Center for Biologics Evaluation and Research (CBER). Approval letter—Yescarta. U.S. Food and Drug Administration (FDA) https://www.fda.gov/media/157539/download (2022).

Kourelis, T. et al. Ethical challenges with CAR T slot allocation with idecabtagene vicleucel manufacturing access. J. Clin. Oncol.40, e20021 (2022).

Article 

Google Scholar 

Al Hadidi, S. et al. Clinical outcome of patients with relapsed refractory multiple myeloma listed for BCMA directed commercial CAR-T therapy. Bone Marrow Transplant. 58, 443–445 (2023).

Ahmed, N. et al. ‘Waitlist mortality’ is high for myeloma patients with limited access to BCMA therapy. Front. Oncol.13, 1206715 (2023).

Article 
PubMed 
PubMed Central 

Google Scholar 

Locke, F. L. et al. Real-world impact of time from leukapheresis to infusion (vein-to-vein time) in patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) treated with axicabtagene ciloleucel. Blood140, 7512–7515 (2022).

Article 

Google Scholar 

Wang, K. et al. A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies. Cytotherapy21, 1081–1093 (2019).

Article 
CAS 
PubMed 

Google Scholar 

Srai, J. S., Badman, C., Krumme, M., Futran, M. & Johnston, C. Future supply chains enabled by continuous processing—opportunities and challenges. May 20–21 2014 Continuous Manufacturing Symposium. J. Pharm. Sci.104, 840–849 (2015).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Abou-el-Enein, M. et al. Scalable manufacturing of CAR T cells for cancer immunotherapy. BloodCancer Discov.2, 408–422 (2021).

CAS 

Google Scholar 

Levine, B. L., Miskin, J., Wonnacott, K. & Keir, C. Global manufacturing of CAR T cell therapy. Mol. Ther. Methods Clin. Dev.4, 92–101 (2017).

Article 
CAS 
PubMed 

Google Scholar 

Myles, L. & Church, T. D. An industry survey of implementation strategies for clinical supply chain management of cell and gene therapies. Cytotherapy24, 344–355 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Papathanasiou, M. M. et al. Autologous CAR T-cell therapies supply chain: challenges and opportunities? CancerGeneTher.27, 799–809 (2020).

CAS 

Google Scholar 

Harrison, R. P., Ruck, S., Medcalf, N. & Rafiq, Q. A. Decentralized manufacturing of cell and gene therapies: overcoming challenges and identifying opportunities. Cytotherapy19, 1140–1151 (2017).

Article 
PubMed 

Google Scholar 

Alqazaqi, R. et al. Geographic and racial disparities in access to chimeric antigen receptor-T cells and bispecific antibodies trials for multiple myeloma. JAMA Netw. Open5, e2228877 (2022).

Article 
PubMed 
PubMed Central 

Google Scholar 

Palani, H. K. et al. Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India. Bone Marrow Transplant. 58, 160–167 (2022).

Iancu, E. M. & Kandalaft, L. E. Challenges and advantages of cell therapy manufacturing under good manufacturing practices within the hospital setting. Curr. Opin. Biotechnol.65, 233–241 (2020).

Article 
CAS 
PubMed 

Google Scholar 

Benjamin, R. et al. UCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial. Lancet Haematol.9, e833–e843 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Benjamin, R. et al. Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies. Lancet396, 1885–1894 (2020).

Article 
CAS 
PubMed 

Google Scholar 

Mailankody, S. et al. Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results. Nat. Med.29, 422–429 (2023).

Article 
CAS 
PubMed 

Google Scholar 

Neelapu, S. S. et al. First-in-human data of ALLO-501 and ALLO-647 in relapsed/refractory large B-cell or follicular lymphoma (R/R LBCL/FL): ALPHA study. J. Clin. Oncol.38, 8002 (2020).

Article 

Google Scholar 

Ghassemi, S. et al. Reducing ex vivo culture improves the antileukemic activity of chimeric antigen receptor (CAR) T cells. Cancer Immunol. Res.6, 1100–1109 (2018).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Ottaviano, G. et al. Phase 1 clinical trial of CRISPR-engineered CAR19 universal T cells for treatment of children with refractory B cell leukemia. Sci. Transl. Med.14, eabq3010 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Chiesa, R. et al. Base-edited CAR7 T cells for relapsed T-cell acute lymphoblastic leukemia. N. Engl. J. Med. 389, 899–910 (2023).

Hu, Y. et al. Genetically modified CD7-targeting allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: a phase I clinical study. Cell Res.32, 995–1007 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Lam, C., Meinert, E., Yang, A. & Cui, Z. Comparison between centralized and decentralized supply chains of autologous chimeric antigen receptor T-cell therapies: a UK case study based on discrete event simulation. Cytotherapy23, 433–451 (2021).

Article 
CAS 
PubMed 

Google Scholar 

Ran, T., Eichmüller, S. B., Schmidt, P. & Schlander, M. Cost of decentralized CAR T‐cell production in an academic nonprofit setting. Int. J. Cancer147, 3438–3445 (2020).

Article 
CAS 
PubMed 

Google Scholar 

Bersenev, A. & Fesnak, A. Place of academic GMP facilities in modern cell therapy. In Cell Reprogramming for Immunotherapy (eds Katz, S. G. & Rabinovich, P. M.) Vol. 2097, 329–339 (Springer, 2020).

Zhu, F. et al. Closed-system manufacturing of CD19 and dual-targeted CD20/19 chimeric antigen receptor T cells using the CliniMACS Prodigy device at an academic medical center. Cytotherapy20, 394–406 (2018).

Article 
CAS 
PubMed 

Google Scholar 

Mock, U. et al. Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS Prodigy. Cytotherapy18, 1002–1011 (2016).

Article 
CAS 
PubMed 

Google Scholar 

Lock, D. et al. Automated, scaled, transposon-based production of CAR T cells. J. Immunother. Cancer10, e005189 (2022).

Article 
PubMed 
PubMed Central 

Google Scholar 

Castella, M. et al. Point-of-care CAR T-cell production (ARI-0001) using a closed semi-automatic bioreactor: experience from an academic phase I clinical trial. Front. Immunol.11, 482 (2020).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Jackson, Z. et al. Automated manufacture of autologous CD19 CAR-T cells for treatment of non-Hodgkin lymphoma. Front. Immunol.11, 1941 (2020).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Shah, N. N. et al. Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial. Nat. Med.26, 1569–1575 (2020).

Article 
CAS 
PubMed 

Google Scholar 

Harrison, R. P., Ruck, S., Rafiq, Q. A. & Medcalf, N. Decentralised manufacturing of cell and gene therapy products: learning from other healthcare sectors. Biotechnol. Adv.36, 345–357 (2018).

Article 
PubMed 

Google Scholar 

Center for Drug Evaluation and Research (CDER). Distributed Manufacturing and Point-of-Care Manufacturing of Drugs https://www.fda.gov/about-fda/reports-budgets-cder/distributed-manufacturing-and-point-care-manufacturing-drugs-discussion-paper (2022).

Chalasani, R., Hershey, T. B. & Gellad, W. F. Cost and access implications of defining CAR-T therapy as a drug. JAMA Health Forum1, e200868 (2020).

Article 
PubMed 

Google Scholar 

U.S. Food & Drug Administration (FDA). FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s) Product List https://public4.pagefreezer.com/browse/FDA/06-02-2023T10:15/https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/fda-regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-product-list (2018).

U.S. Food & Drug Administration (FDA). Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use https://www.fda.gov/media/109176/download (2020).

U.S. Food & Drug Administration (FDA). Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception https://www.fda.gov/regulatory-information/search-fda-guidance-documents/same-surgical-procedure-exception-under-21-cfr-127115b-questions-and-answers-regarding-scope (2017).

Nagai, S. Regulatory hurdles for CAR T-cell therapy in Japan. Lancet Haematol.8, e686–e687 (2021).

Article 
CAS 
PubMed 

Google Scholar 

U.S. Food & Drug Administration (FDA). Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers https://www.fda.gov/media/131911/download (2019).

U.S. Food & Drug Administration (FDA). Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstration-comparability-human-biological-products-including-therapeutic-biotechnology-derived (1996).

Better, M., Chiruvolu, V. & Sabatino, M. Overcoming challenges for engineered autologous T cell therapies. CellGeneTher. Insights4, 173–186 (2018).

Google Scholar 

U.S. Food & Drug Administration (FDA). Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products https://www.fda.gov/media/156896/download (2022).

Marks, P. & Gottlieb, S. Balancing safety and innovation for cell-based regenerative medicine. N. Engl. J. Med.378, 954–959 (2018).

Article 
PubMed 

Google Scholar 

Marks, P. & Gottlieb, S. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on New Policies to Advance Development of Safe and Effective Cell and Gene Therapies https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics (2019).

Medicines & Healthcare products Regulatory Agency (MHRA). Consultation on Point of Care Manufacturing https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing (2021).

Nizzi, F. Redefining the role of blood establishments as raw material suppliers, manufacturers, and distributors for new cell therapies: the Blood Systems experience. Transfusion56, 29S–31S (2016).

Article 
PubMed 

Google Scholar 

Coppens, D. G. et al. Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries. Regen. Med.15, 2015–2028 (2020).

Article 
CAS 
PubMed 

Google Scholar 

Coppens, D. G. M. et al. Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries. Cytotherapy22, 592–600 (2020).

Article 
PubMed 

Google Scholar 

Trias, E., Juan, M., Urbano-Ispizua, A. & Calvo, G. The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001. Bone Marrow Transplant.57, 156–159 (2022).

Article 
PubMed 
PubMed Central 

Google Scholar 

Ortíz-Maldonado, V. et al. CART19-BE-01: a multicenter trial of ARI-0001 cell therapy in patients with CD19+ relapsed/refractory malignancies. Mol. Ther.29, 636–644 (2021).

Article 
PubMed 

Google Scholar 

Therapeutic Goods Administration. Autologous Human Cells and Tissues Products Regulation https://www.tga.gov.au/resources/resource/guidance/autologous-human-cells-and-tissues-products-regulation (2019).

Ivaskiene, T., Mauricas, M. & Ivaska, J. Hospital exemption for advanced therapy medicinal products: issue in application in the European Union Member States. Curr.StemCell Res. Ther.12, 45–51 (2016).

Google Scholar 

Cuende, N. et al. The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders’ concerns. Cytotherapy16, 1597–1600 (2014).

Article 
PubMed 

Google Scholar 

The Alliance for Regenerative Medicine. Recommendations for the Use of Hospital Exemption http://alliancerm.org/wp-content/uploads/2020/10/ARM-position-on-HE-final-Oct-2020.pdf (2020).

EFPIA & EBE. Hospital exemption for advanced therapy medicinal products (ATMPs): greater transparency needed in order to improve patient safety and access to ATMPs. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/10102017-ebe-and-efpia-call-on-the-eu-commission-and-member-states-to-improve-transparency-on-hospital-exemptions-for-advanced-therapies/ (2017).

Cuende, N. et al. Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products. Cytotherapy24, 686–690 (2022).

Article 
PubMed 

Google Scholar 

Warkentin, P. I. Voluntary accreditation of cellular therapies: Foundation for the Accreditation of Cellular Therapy (FACT). Cytotherapy5, 299–305 (2003).

Article 
CAS 
PubMed 

Google Scholar 

Maus, M. V. & Nikiforow, S. The why, what, and how of the new FACT standards for immune effector cells. J. Immunother. Cancer5, 36 (2017).

Article 
PubMed 
PubMed Central 

Google Scholar 

Hort, S. et al. Toward rapid, widely available autologous CAR-T cell therapy—artificial intelligence and automation enabling the smart manufacturing hospital. Front. Med.9, 913287 (2022).

Article 

Google Scholar 

Blache, U., Popp, G., Dünkel, A., Koehl, U. & Fricke, S. Potential solutions for manufacture of CAR T cells in cancer immunotherapy. Nat. Commun.13, 5225 (2022).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Soler, M. & Lechuga, L. Boosting cancer immunotherapies with optical biosensor nanotechnologies. Eur. Med. J.4, 124–132 (2019).

Article 

Google Scholar 

Oh, B.-R. et al. Integrated nanoplasmonic sensing for cellular functional immunoanalysis using human blood. ACSNano8, 2667–2676 (2014).

CAS 

Google Scholar 

Oh, B.-R. et al. Multiplexed nanoplasmonic temporal profiling of T-cell response under immunomodulatory agent exposure. ACS Sens.1, 941–948 (2016).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Raphael, M. P., Christodoulides, J. A., Delehanty, J. B., Long, J. P. & Byers, J. M. Quantitative imaging of protein secretions from single cells in real time. Biophys. J.105, 602–608 (2013).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Kurucz, I. et al. Label-free optical biosensor for on-line monitoring the integrated response of human B cells upon the engagement of stimulatory and inhibitory immune receptors. Sens. Actuators B Chem.240, 528–535 (2017).

Article 
CAS 

Google Scholar 

Soler, M. et al. Two-dimensional label-free affinity analysis of tumor-specific CD8 T cells with a biomimetic plasmonic sensor. ACS Sens.3, 2286–2295 (2018).

Article 
CAS 
PubMed 

Google Scholar 

Walsh, A. J. et al. Classification of T-cell activation via autofluorescence lifetime imaging. Nat. Biomed. Eng.5, 77–88 (2020).

Article 
PubMed 
PubMed Central 

Google Scholar 

Rossoff, J. et al. Out-of-specification tisagenlecleucel does not compromise safety or efficacy in pediatric acute lymphoblastic leukemia. Blood138, 2138–2142 (2021).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Jacobson, C. A. et al. Outcomes of patients (Pts) in ZUMA-9, a multicenter, open-label study of axicabtagene ciloleucel (axi-cel) in relapsed/refractory large B cell lymphoma (R/R LBCL) for expanded access and commercial out-of-specification (OOS) product. Blood136, 2–3 (2020).

Article 

Google Scholar 

Chong, E. A. et al. CAR T cell viability release testing and clinical outcomes: is there a lower limit? Blood134, 1873–1875 (2019).

Article 
PubMed 
PubMed Central 

Google Scholar 

U.S. Food & Drug Administration (FDA). Approval Order—CliniMACS CD34 Reagent System https://wayback.archive-it.org/7993/20190208123839/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm382986.htm (2014).

U.S. Food & Drug Administration (FDA). Getting a Humanitarian Use Device to Market https://www.fda.gov/medical-devices/humanitarian-device-exemption/getting-humanitarian-use-device-market (2022).

Priesner, C. et al. Automated enrichment, transduction, and expansion of clinical-scale CD62L+ T cells for manufacturing of gene therapy medicinal products. Hum.GeneTher.27, 860–869 (2016).

CAS 

Google Scholar 

Lock, D. et al. Automated manufacturing of potent CD20-directed chimeric antigen receptor T cells for clinical use. Hum.GeneTher.28, 914–925 (2017).

CAS 

Google Scholar 

Blaeschke, F. et al. Induction of a central memory and stem cell memory phenotype in functionally active CD4+ and CD8+ CAR T cells produced in an automated good manufacturing practice system for the treatment of CD19+ acute lymphoblastic leukemia. Cancer Immunol. Immunother.67, 1053–1066 (2018).

Article 
CAS 
PubMed 

Google Scholar 

Castella, M. et al. Development of a novel anti-CD19 chimeric antigen receptor: a paradigm for an affordable CAR T cell production at academic institutions. Mol. Ther. Methods Clin. Dev.12, 134–144 (2019).

Article 
CAS 
PubMed 

Google Scholar 

Zhang, W., Jordan, K. R., Schulte, B. & Purev, E. Characterization of clinical grade CD19 chimeric antigen receptor T cells produced using automated CliniMACS Prodigy system. DrugDes. Devel.Ther.12, 3343–3356 (2018).

CAS 

Google Scholar 

Aleksandrova, K. et al. Functionality and cell senescence of CD4/ CD8-selected CD20 CAR T cells manufactured using the automated CliniMACS Prodigy® platform. Transfus. Med.Hemother.46, 47–54 (2019).

Google Scholar 

Fernández, L. et al. GMP-compliant manufacturing of NKG2D CAR memory T cells using CliniMACS Prodigy. Front. Immunol.10, 2361 (2019).

Article 
PubMed 
PubMed Central 

Google Scholar 

Vedvyas, Y. et al. Manufacturing and preclinical validation of CAR T cells targeting ICAM-1 for advanced thyroid cancer therapy. Sci. Rep.9, 10634 (2019).

Article 
PubMed 
PubMed Central 

Google Scholar 

Arcangeli, S. et al. Next-generation manufacturing protocols enriching TSCM CAR T cells can overcome disease-specific T cell defects in cancer patients. Front. Immunol.11, 1217 (2020).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Bozza, M. et al. A nonviral, nonintegrating DNA nanovector platform for the safe, rapid, and persistent manufacture of recombinant T cells. Sci. Adv.7, eabf1333 (2021).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Palen, K., Zurko, J., Johnson, B. D., Hari, P. & Shah, N. N. Manufacturing chimeric antigen receptor T cells from cryopreserved peripheral blood cells: time for a collect-and-freeze model? Cytotherapy23, 985–990 (2021).

Article 
CAS 
PubMed 

Google Scholar 

Glienke, W. et al. GMP-compliant manufacturing of TRUCKs: CAR T cells targeting GD2 and releasing inducible IL-18. Front. Immunol.13, 839783 (2022).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

Joedicke, J. J. et al. Accelerating clinical-scale production of BCMA CAR T cells with defined maturation stages. Mol. Ther. Methods Clin. Dev.24, 181–198 (2022).

Article 
CAS 
PubMed 

Google Scholar 

Nicod, C. et al. CAR-T cells targeting IL-1RAP produced in a closed semiautomatic system are ready for the first phase I clinical investigation in humans. Curr. Res. Transl. Med.71, 103385 (2023).

CAS 
PubMed 

Google Scholar 

Maschan, M. et al. Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients. Nat. Commun.12, 7200 (2021).

Article 
CAS 
PubMed 
PubMed Central 

Google Scholar 

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Nature.com – https://www.nature.com/articles/s41587-023-01981-8

Exit mobile version