{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:30:10Z","timestamp":1787225410526,"version":"build-2736575974"},"reference-count":97,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:p>Chimeric antigen receptor (CAR) T-cell therapy is a transformative modality for refractory hematologic malignancies; however, its adoption in Latin America and the Caribbean (LAC) is severely constrained by prohibitive manufacturing costs, limited specialized infrastructure, and fragmented regulatory frameworks. To address this translational gap, we propose a pragmatic, cost-adapted model for establishing Good Manufacturing Practice (GMP) laboratories tailored to the socioeconomic realities of LAC. This model advocates for decentralized, modular cleanroom facilities that integrate fully closed automated manufacturing platforms with risk-based quality management systems. Furthermore, we emphasize the strategic implementation of artificial intelligence (AI) and digital health tools\u2014such as electronic batch records and predictive analytics\u2014to optimize resource utilization and ensure stringent regulatory compliance. Essential to this framework is the cultivation of a specialized local workforce and the promotion of regional regulatory harmonization through initiatives like PAHO\u2019s Red PARF. Ultimately, this scalable approach provides a realistic roadmap to democratize CAR T-cell therapy in LAC, fostering regional biomanufacturing autonomy and promoting equitable patient access.<\/jats:p>","DOI":"10.3389\/fpubh.2026.1875553","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:12:02Z","timestamp":1787224322000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A proposal of good manufacturing practices (GMP) laboratory for CAR T-cell therapy in Latin America and the Caribbean: challenges and opportunities"],"prefix":"10.3389","volume":"14","author":[{"given":"Sergio Camilo","family":"Cabrera-Salcedo","sequence":"first","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad Icesi","place":["Cali, Colombia"]},{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis Gabriel","family":"Parra-Lara","sequence":"additional","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad Icesi","place":["Cali, Colombia"]},{"name":"Centro de Investigaciones Cl\u00ednicas, Unidad de Inteligencia Artificial, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]},{"name":"Service of Clinical Oncology, Department of Internal Medicine, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Fernandes-Pineda","sequence":"additional","affiliation":[{"name":"Service of Clinical Oncology, Department of Internal Medicine, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandro","family":"Toro-Pedroza","sequence":"additional","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad Icesi","place":["Cali, Colombia"]},{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Sebastian Victoria","family":"Hincapie","sequence":"additional","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad Icesi","place":["Cali, Colombia"]},{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lady J.","family":"Rios-Serna","sequence":"additional","affiliation":[{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Universidad Icesi, CIRAT: Centro de Investigaci\u00f3n en Reumatolog\u00eda, Autoinmunidad y Medicina Traslacional","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Loukanov","sequence":"additional","affiliation":[{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Department of Chemistry and Materials Science, National Institute of Technology, Gunma College","place":["Maebashi, Japan"]},{"name":"Laboratory of Engineering Nanobiotechnology, University of Mining and Geology \"St. Ivan Rilski\"","place":["Sofia, Bulgaria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Ortiz-Guzman","sequence":"additional","affiliation":[{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Minos LLC, Department of Research and Development","place":["Miami, FL, United States"]},{"name":"Prodigy Cells Labs, LLC","place":["Doral, FL, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Esteban","family":"Garcia-Robledo","sequence":"additional","affiliation":[{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Centro de Investigaci\u00f3n Hemato Oncol\u00f3gico (CIHO), IDC Instituto de C\u00e1ncer Hemato Onc\u00f3logos","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos A.","family":"Ca\u00f1as","sequence":"additional","affiliation":[{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Universidad Icesi, CIRAT: Centro de Investigaci\u00f3n en Reumatolog\u00eda, Autoinmunidad y Medicina Traslacional","place":["Cali, Colombia"]},{"name":"Division of Rheumatology, Department of Medicine, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo Adolfo","family":"Cruz-Suarez","sequence":"additional","affiliation":[{"name":"Centro de Investigaciones Cl\u00ednicas, Unidad de Inteligencia Artificial, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]},{"name":"Departamento de Salud P\u00fablica y Medicina Comunitaria, Universidad Icesi","place":["Cali, Valle del Cauca, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe Ocampo","family":"Osorio","sequence":"additional","affiliation":[{"name":"Centro de Investigaciones Cl\u00ednicas, Unidad de Inteligencia Artificial, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]},{"name":"Departamento de Salud P\u00fablica y Medicina Comunitaria, Universidad Icesi","place":["Cali, Valle del Cauca, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael P.","family":"Gustafson","sequence":"additional","affiliation":[{"name":"Department of Laboratory of Medicine and Pathology, Mayo Clinic in Arizona","place":["Scottsdale, AZ, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Guillermo","family":"Restrepo","sequence":"additional","affiliation":[{"name":"Service of Clinical Oncology, Department of Internal Medicine, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andres","family":"Mosquera","sequence":"additional","affiliation":[{"name":"Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, and Houston Methodist Hospital","place":["Houston, TX, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Hoyos","sequence":"additional","affiliation":[{"name":"Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, and Houston Methodist Hospital","place":["Houston, TX, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan C.","family":"Baena","sequence":"additional","affiliation":[{"name":"Facultad de Ciencias de la Salud, Universidad Icesi","place":["Cali, Colombia"]},{"name":"LiliCAR-T Group, Fundaci\u00f3n Valle del Lili, Icesi","place":["Cali, Colombia"]},{"name":"Service of Clinical Oncology, Department of Internal Medicine, Fundaci\u00f3n Valle del Lili","place":["Cali, Colombia"]},{"name":"Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, and Houston Methodist Hospital","place":["Houston, TX, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,20]]},"reference":[{"key":"ref1","volume-title":"International Standards for Hematopoietic cellular Therapy product Collection, Processing, and Administration: Accreditation Manual","year":"2021"},{"key":"ref2","volume-title":"WHO Good Manufacturing Practices for Biological Products. Annex 2 (WHO Tech Rep Ser No. 999)","year":"2016"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"957","DOI":"10.1177\/009286159402800408","article-title":"Good manufacturing practice: an historical overview and actual status","volume":"28","author":"Heir","year":"1994","journal-title":"Drug Inf J"},{"key":"ref4","volume-title":"Decade-Long Remission for two Patients after CAR T Cell Therapy","year":"2022"},{"key":"ref5","volume-title":"Novartis Receives first ever FDA Approval for a CAR-T cell Therapy, Kymriah (CTL019), for children and young Adults with B-cell ALL that is Refractory or has Relapsed at least Twice","year":"2017"},{"key":"ref6","volume-title":"CEPALSTAT: portal de datos y publicaciones estad\u00edsticas","year":"2022"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"100294","DOI":"10.1016\/j.lana.2022.100294","article-title":"An updated profile of the cancer burden, patterns and trends in Latin America and the Caribbean","volume":"13","author":"Pi\u00f1eros","year":"2022","journal-title":"Lancet Reg Health Am"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"eadn1902","DOI":"10.1126\/scitranslmed.adn1902","article-title":"The translational gap for gene therapies in low- and middle-income countries","volume":"16","author":"Doxzen","year":"2024","journal-title":"Sci Transl Med"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1432799","DOI":"10.3389\/fimmu.2024.1432799","article-title":"ReCARving the future: bridging CAR T-cell therapy gaps with synthetic biology, engineering, and economic insights","volume":"15","author":"Ali","year":"2024","journal-title":"Front Immunol"},{"key":"ref10","volume-title":"EudraLex \u2014 The Rules Governing Medicinal Products in the European Union. Volume 4: EU Guidelines for Good Manufacturing Practice","year":"2008"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"314","DOI":"10.3343\/alm.2023.0382","article-title":"Manufacturing cell and gene therapies: challenges in clinical translation","volume":"44","author":"Lee","year":"2023","journal-title":"Ann Lab Med"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"873","DOI":"10.1016\/j.jcyt.2018.05.003","article-title":"Centralised versus decentralised manufacturing and the delivery of healthcare products: a United Kingdom exemplar","volume":"20","author":"Harrison","year":"2018","journal-title":"Cytotherapy"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"164","DOI":"10.1016\/j.copbio.2018.01.025","article-title":"A guide to manufacturing CAR T cell therapies","volume":"53","author":"Vormittag","year":"2018","journal-title":"Curr Opin Biotechnol"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1158\/2643-3230.BCD-21-0084","article-title":"Scalable manufacturing of CAR T cells for cancer immunotherapy","volume":"2","author":"Abou-El-Enein","year":"2021","journal-title":"Blood Cancer Discov"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"6131","DOI":"10.1182\/bloodadvances.2024014653","article-title":"Charting the course for CAR T-cell manufacturing","volume":"8","author":"Elsallab","year":"2024","journal-title":"Blood Adv"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"1140","DOI":"10.1016\/j.jcyt.2017.07.005","article-title":"Decentralized manufacturing of cell and gene therapies: overcoming challenges and identifying opportunities","volume":"19","author":"Harrison","year":"2017","journal-title":"Cytotherapy"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1186\/s12967-025-06400-x","article-title":"Surveying local CAR T-cell manufacturing processes to facilitate standardization and expand accessibility","volume":"23","author":"Gupta","year":"2025","journal-title":"J Transl Med"},{"key":"ref18","volume-title":"The EBMT Handbook: Hematopoietic cell Transplantation and cellular Therapies","author":"Saccardi","year":"2024"},{"key":"ref19","volume-title":"WHO Guidelines on good Manufacturing Practices for Blood Establishments","year":"2011"},{"key":"ref20","volume-title":"Good Manufacturing Practices for sterile Pharmaceutical Products","year":"2011"},{"key":"ref21","volume-title":"GMP & modular Cleanrooms: Ensuring Quality & Safety","year":"2024"},{"key":"ref22","volume-title":"ISPE Baseline guide vol 6: Biopharmaceutical Manufacturing Facilities","author":"Berk","year":"2023"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"1238535","DOI":"10.3389\/frtra.2023.1238535","article-title":"Promises and challenges of a decentralized CAR T-cell manufacturing model","volume":"2","author":"Shah","year":"2023","journal-title":"Front Transplant"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"6133","DOI":"10.1182\/bloodadvances.2024012982","article-title":"Point-of-care CAR T manufacturing solutions: can 1 model fit all?","volume":"8","author":"Urbano-Ispizua","year":"2024","journal-title":"Blood Adv"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"803","DOI":"10.2217\/rme-2017-0051","article-title":"Challenges of running a GMP facility for regenerative medicine in a public hospital","volume":"12","author":"Vigan\u00f2","year":"2017","journal-title":"Regen Med"},{"key":"ref26","volume-title":"ISO 14644-1:2015. Cleanrooms and Associated Controlled Environments \u2014 Part 1: Classification of air Cleanliness by Particle Concentration","year":"2015"},{"key":"ref27","volume-title":"Current Good Manufacturing Practice (CGMP) Regulations","year":"2025"},{"key":"ref28","volume-title":"Good manufacturing practice. Compliance: Research and Development","year":"2025"},{"key":"ref29","year":""},{"key":"ref30","volume-title":"How Classification Impacts the design of a Cleanroom","author":"Lipeles","year":"2018"},{"key":"ref31","first-page":"4","article-title":"Airborne particle counting with an LSAPC","volume":"49","author":"Whyte","year":"2023","journal-title":"Clean Air Contain Rev"},{"key":"ref32","volume-title":"What is a GMP Cleanroom? A Comprehensive Overview","year":"2024"},{"key":"ref33","volume-title":"GMP Facility: Understanding grade A, grade B, grade C and D","year":"2021"},{"key":"ref34","volume-title":"Pharmaceutical Cleanroom design & ISO 14644-16","year":"2021"},{"key":"ref35","volume-title":"Annex 1: Manufacture of sterile Products","year":"2022"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"e51309","DOI":"10.7759\/cureus.51309","article-title":"The role of the biosafety cabinet in preventing infection in the clinical laboratory","volume":"15","author":"Jagtap","year":"2023","journal-title":"Cureus"},{"key":"ref37","volume-title":"What is a HEPA Filter? Indoor air Quality (IAQ)","year":"2024"},{"key":"ref38","doi-asserted-by":"publisher","first-page":"111502","DOI":"10.1016\/j.enbuild.2021.111502","article-title":"Study on pressure control and energy saving of cleanroom in purification air conditioning system","volume":"253","author":"Liu","year":"2021","journal-title":"Energ Buildings"},{"key":"ref39","volume-title":"Room differential Pressures in Facility design: Fundamentals","year":"2024"},{"key":"ref40","article-title":"Temperature & humidity requirements in pharmaceutical facilities","author":"Haycocks","year":"2021","journal-title":"Pharm Eng"},{"key":"ref41","first-page":"351","article-title":"Indirect health effects of relative humidity in indoor environments","volume":"65","author":"Arundel","year":"1986","journal-title":"Environ Health Perspect"},{"key":"ref42","volume-title":"Effective Management of Environmental Controls in GLP Laboratories: how to Manage Environmental Controls in GLP-Compliant Laboratories","year":"2025"},{"key":"ref43","volume-title":"Quality Control Guidelines. Health Products Policy and Standards","year":"2025"},{"key":"ref44","volume-title":"Red Panamericana para la Armonizaci\u00f3n de la Reglamentaci\u00f3n Farmac\u00e9utica (Red PARF)","year":"2025"},{"key":"ref45","volume-title":"ICH Harmonised Guideline: Quality risk Management Q9(R1)","year":"2023"},{"key":"ref46","doi-asserted-by":"publisher","first-page":"323","DOI":"10.1016\/j.jcyt.2022.10.012","article-title":"A novel predictive algorithm to personalize autologous T-cell harvest for chimeric antigen receptor T-cell manufacture","volume":"25","author":"O'Reilly","year":"2023","journal-title":"Cytotherapy"},{"key":"ref47","doi-asserted-by":"publisher","first-page":"e1009883","DOI":"10.1371\/journal.pcbi.1009883","article-title":"In vitro machine learning-based CAR T immunological synapse quality measurements correlate with patient clinical outcomes","volume":"18","author":"Naghizadeh","year":"2022","journal-title":"PLoS Comput Biol"},{"key":"ref48","doi-asserted-by":"publisher","first-page":"e007073","DOI":"10.1136\/jitc-2023-007073","article-title":"Current perspectives on mass spectrometry-based immunopeptidomics: the computational angle to tumor antigen discovery","volume":"11","author":"Zhang","year":"2023","journal-title":"J Immunother Cancer"},{"key":"ref49","volume-title":"Eight Guiding Principles of digital Transformation of the Health sector: a call to Pan American action","year":"2021"},{"key":"ref50","volume-title":"Artificial Intelligence in public Health: Readiness Assessment Toolkit","year":"2024"},{"key":"ref51","doi-asserted-by":"publisher","first-page":"5225","DOI":"10.1038\/s41467-022-32866-0","article-title":"Potential solutions for manufacture of CAR T cells in cancer immunotherapy","volume":"13","author":"Blache","year":"2022","journal-title":"Nat Commun"},{"key":"ref52","doi-asserted-by":"publisher","first-page":"1635159","DOI":"10.3389\/fimmu.2025.1635159","article-title":"Smart CAR-T Nanosymbionts: archetypes and proto-models","volume":"16","author":"Baena","year":"2025","journal-title":"Front Immunol"},{"key":"ref53","doi-asserted-by":"publisher","first-page":"e0000022","DOI":"10.1371\/journal.pdig.0000022","article-title":"Sources of bias in artificial intelligence that perpetuate healthcare disparities-a global review","volume":"1","author":"Celi","year":"2022","journal-title":"PLOS Digit Health"},{"key":"ref54","doi-asserted-by":"publisher","first-page":"154796","DOI":"10.1016\/j.jcrc.2024.154796","article-title":"Minimizing bias when using artificial intelligence in critical care medicine","volume":"82","author":"Ranard","year":"2024","journal-title":"J Crit Care"},{"key":"ref55","doi-asserted-by":"publisher","first-page":"20230023","DOI":"10.1259\/bjr.20230023","article-title":"AI pitfalls and what not to do: mitigating bias in AI","volume":"96","author":"Gichoya","year":"2023","journal-title":"Br J Radiol"},{"key":"ref56","doi-asserted-by":"publisher","first-page":"18005","DOI":"10.1007\/s11042-023-16029-x","article-title":"Artificial intelligence bias in medical system designs: a systematic review","volume":"83","author":"Kumar","year":"2023","journal-title":"Multimed Tools Appl"},{"key":"ref57","doi-asserted-by":"publisher","first-page":"e0000278","DOI":"10.1371\/journal.pdig.0000278","article-title":"Bias in artificial intelligence algorithms and recommendations for mitigation","volume":"2","author":"Nazer","year":"2023","journal-title":"PLOS Digit Health"},{"key":"ref58","doi-asserted-by":"publisher","first-page":"1597","DOI":"10.1038\/s41565-024-01754-7","article-title":"A translational framework to DELIVER nanomedicines to the clinic","volume":"19","author":"Joyce","year":"2024","journal-title":"Nat Nanotechnol"},{"key":"ref59","doi-asserted-by":"publisher","first-page":"1311","DOI":"10.1038\/s43018-025-01025-x","article-title":"Nanotechnology for immuno-oncology","volume":"6","author":"Grippin","year":"2025","journal-title":"Nat Can"},{"key":"ref60","doi-asserted-by":"publisher","first-page":"100193","DOI":"10.1016\/j.onano.2023.100193","article-title":"Drug loading comparison of commercial ibuprofen on magnetite nanoparticles surface by UV\u2013vis spectrophotometry and acid-alkali titration by a factorial design of experiments","volume":"14","author":"Ocampo Osorio","year":"2023","journal-title":"OpenNano"},{"key":"ref61","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1007\/s00604-025-06989-2","article-title":"A scalable and autoclavable oxygen nanosensor platform for metabolic monitoring of Saccharomyces cerevisiae in a bioreactor and other in situ systems","volume":"192","author":"Saccomano","year":"2025","journal-title":"Microchim Acta"},{"key":"ref62","doi-asserted-by":"publisher","first-page":"114124","DOI":"10.1016\/j.bios.2022.114124","article-title":"Nanosensors in clinical development of CAR-T cell immunotherapy","volume":"206","author":"Nguyen-Le","year":"2022","journal-title":"Biosens Bioelectron"},{"key":"ref63","doi-asserted-by":"publisher","first-page":"1","DOI":"10.5455\/JCRR.20240205070256","article-title":"Nanosensors for early detection and diagnosis of cancer: a review of recent advances","volume":"1","author":"Eissa","year":"2024","journal-title":"J Cancer Res Rev"},{"key":"ref64","doi-asserted-by":"publisher","first-page":"e2407478","DOI":"10.1002\/smll.202407478","article-title":"Nanofluidic lab-on-a-chip systems for biosensing in healthcare","volume":"21","author":"Chong","year":"2025","journal-title":"Small"},{"key":"ref65","doi-asserted-by":"publisher","first-page":"2942","DOI":"10.1039\/d2lc01076c","article-title":"Integrated \"lab-on-a-chip\" microfluidic systems for isolation, enrichment, and analysis of cancer biomarkers","volume":"23","author":"Surappa","year":"2023","journal-title":"Lab Chip"},{"key":"ref66","doi-asserted-by":"publisher","first-page":"97737","DOI":"10.12998\/wjcc.v13.i3.97737","article-title":"Advancing healthcare through laboratory on a chip technology: transforming microorganism identification and diagnostics","volume":"13","author":"Ardila","year":"2025","journal-title":"World J Clin Cases"},{"key":"ref67","doi-asserted-by":"publisher","first-page":"4526","DOI":"10.7150\/thno.87266","article-title":"Organ-on-a-chip meets artificial intelligence in drug evaluation","volume":"13","author":"Deng","year":"2023","journal-title":"Theranostics"},{"key":"ref68","doi-asserted-by":"publisher","first-page":"e2203169","DOI":"10.1002\/smll.202203169","article-title":"Recent advances of utilizing artificial intelligence in lab on a Chip for diagnosis and treatment","volume":"18","author":"Zare Harofte","year":"2022","journal-title":"Small"},{"key":"ref69","doi-asserted-by":"publisher","first-page":"2144","DOI":"10.1002\/bit.28486","article-title":"Machine learning-based model predictive controller design for cell culture processes","volume":"120","author":"Rashedi","year":"2023","journal-title":"Biotechnol Bioeng"},{"key":"ref70","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1038\/s41408-021-00459-7","article-title":"CAR-T cell therapy: current limitations and potential strategies","volume":"11","author":"Sterner","year":"2021","journal-title":"Blood Cancer J"},{"key":"ref71","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1016\/j.omtm.2016.12.006","article-title":"Global manufacturing of CAR T cell therapy","volume":"4","author":"Levine","year":"2016","journal-title":"Mol Ther Methods Clin Dev"},{"key":"ref72","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1186\/s43046-025-00262-6","article-title":"From lab to lifesaver: the rise of CAR T-cell therapy in oncology","volume":"37","author":"Jangavali","year":"2025","journal-title":"J Egypt Natl Canc Inst"},{"key":"ref73","volume-title":"Fiocruz and Caring Cross Announce Collaboration Agreement to Enable Access to Affordable CAR-T Therapy in Brazil and Latin America","author":"Caring","year":"2024"},{"key":"ref74","volume-title":"Fiocruz and Caring Cross look to Slash CAR-T Costs in LATAM","author":"Q","year":"2024"},{"key":"ref75","doi-asserted-by":"publisher","first-page":"100995","DOI":"10.1016\/j.lana.2025.100995","article-title":"Clinical trials to gene therapy development and production in Brazil: a review","volume":"43","author":"Morales Saute","year":"2025","journal-title":"Lancet Reg Health Am"},{"key":"ref76","doi-asserted-by":"publisher","first-page":"101114","DOI":"10.1016\/j.omtm.2023.101114","article-title":"Development of an automated manufacturing process for large-scale production of autologous T cell therapies","volume":"31","author":"Francis","year":"2023","journal-title":"Mol Ther Methods Clin Dev"},{"key":"ref77","doi-asserted-by":"publisher","first-page":"S139","DOI":"10.1016\/j.jcyt.2025.03.272","article-title":"Real world manufacturing outcomes of automated cell therapy production on the Lonza cocoon\u00ae platform in a phase 2 clinical trial","volume":"27","author":"Danis","year":"2025","journal-title":"Cytotherapy"},{"key":"ref78","doi-asserted-by":"publisher","first-page":"1612248","DOI":"10.3389\/fbioe.2025.1612248","article-title":"Industrializing CAR-T cell therapy: impact of automation on cost and space efficiency of manufacturing facilities","volume":"13","author":"Weltin","year":"2026","journal-title":"Front Bioeng Biotechnol"},{"key":"ref79","doi-asserted-by":"publisher","first-page":"e70067","DOI":"10.1002\/elsc.70067","article-title":"Process systems engineering in precision medicine: opportunities in autologous CAR-T therapy","volume":"26","author":"B","year":"2026","journal-title":"Eng Life Sci"},{"key":"ref80","doi-asserted-by":"publisher","first-page":"1183","DOI":"10.15252\/emmm.201607485","article-title":"Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts","volume":"9","author":"Hartmann","year":"2017","journal-title":"EMBO Mol Med"},{"key":"ref81","doi-asserted-by":"publisher","first-page":"156","DOI":"10.1038\/s41409-021-01463-y","article-title":"The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001","volume":"57","author":"Trias","year":"2022","journal-title":"Bone Marrow Transplant"},{"key":"ref82","volume-title":"The impact of CAR T cell Patenting on Access to Therapy in Canada","author":"Nathaniel","year":"2021"},{"key":"ref83","volume-title":"Caring Cross and Fiocruz Partner for Low-Cost CAR-T Manufacturing in Brazil. Genetic Engineering and Biotechnology News","author":"Gareth John","year":"2024"},{"key":"ref84","volume-title":"Nutera Advanced Therapy Center will produce CAR T-cells for use in Clinical trial of cancer Treatment. Agency FAPESP","author":"Maria Fernanda","year":"2023"},{"key":"ref85","doi-asserted-by":"publisher","first-page":"913287","DOI":"10.3389\/fmed.2022.913287","article-title":"Toward rapid, widely available autologous CAR-T cell therapy - artificial intelligence and automation enabling the smart manufacturing hospital","volume":"9","author":"Hort","year":"2022","journal-title":"Front Med (Lausanne)"},{"key":"ref86","doi-asserted-by":"publisher","first-page":"25151355241305856","DOI":"10.1177\/25151355241305856","article-title":"Artificial intelligence for chimeric antigen receptor-based therapies: a comprehensive review of current applications and future perspectives","volume":"12","author":"Shahzadi","year":"2024","journal-title":"Ther Adv Vaccines Immunother"},{"key":"ref87","doi-asserted-by":"publisher","first-page":"1310002","DOI":"10.3389\/fmmed.2024.1310002","article-title":"Current advances in experimental and computational approaches to enhance CAR T cell manufacturing protocols and improve clinical efficacy","volume":"4","author":"Colina","year":"2024","journal-title":"Front Mol Med"},{"key":"ref88","doi-asserted-by":"publisher","first-page":"113561","DOI":"10.1016\/j.jconrel.2025.02.057","article-title":"Automated manufacturing of cell therapies","volume":"381","author":"Melocchi","year":"2025","journal-title":"J Control Release"},{"key":"ref89","doi-asserted-by":"publisher","first-page":"4825","DOI":"10.2147\/DDDT.S80403","article-title":"How we make cell therapy in Italy","volume":"9","author":"Montemurro","year":"2015","journal-title":"Drug Des Devel Ther"},{"key":"ref90","doi-asserted-by":"publisher","first-page":"101614","DOI":"10.1016\/j.beha.2025.101614","article-title":"Creating a GMP cell processing program: a focus on quality and regulation","volume":"38","author":"Patel","year":"2025","journal-title":"Best Pract Res Clin Haematol"},{"key":"ref91","volume-title":"CAR-T Therapy: Escalating Costs in an Expanding Market","author":"Pulice","year":"2026"},{"key":"ref92","doi-asserted-by":"publisher","first-page":"105153","DOI":"10.1016\/j.healthpol.2024.105153","article-title":"Availability and financing of CAR-T cell therapies: a cross-country comparative analysis","volume":"149","author":"Litvinova","year":"2024","journal-title":"Health Policy (New York)"},{"key":"ref93","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1186\/s13023-026-04320-7","article-title":"Increasing access to CAR-T therapy: a case study of an academic hospital\u2019s alternative innovation model","volume":"21","author":"Ruiz","year":"2026","journal-title":"Orphanet J Rare Dis"},{"key":"ref94","doi-asserted-by":"publisher","first-page":"10","DOI":"10.31547\/bct-2023-023","article-title":"Challenges in Global Access to CAR-T cells: an Asian Perspective","volume":"7","author":"Hwang","year":"2023","journal-title":"Blood Cell Ther"},{"key":"ref95","article-title":"ImmunoACT achieves profitability with India's first CAR-T therapy, treating over 350 Cancer patients","year":"","journal-title":"MedPath Trial [A\u00f1o]"},{"key":"ref96","doi-asserted-by":"publisher","first-page":"1715536","DOI":"10.1080\/20016689.2020.1715536","article-title":"Outcomes-based reimbursement for gene therapies in practice: the experience of recently launched CAR-T cell therapies in major European countries","volume":"8","author":"J\u00f8rgensen","year":"2020","journal-title":"J Mark Access Health Policy"},{"key":"ref97","doi-asserted-by":"publisher","first-page":"1521","DOI":"10.1182\/blood.2025030872","article-title":"Global access to commercial CAR T-cell therapies: a cross-sectional study of health technology assessment across the G20 countries","volume":"147","author":"Ge","year":"2026","journal-title":"Blood"}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1875553\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:12:09Z","timestamp":1787224329000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1875553\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,20]]},"references-count":97,"alternative-id":["10.3389\/fpubh.2026.1875553"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2026.1875553","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,20]]},"article-number":"1875553"}}