{"entity":{"id":"viral-vector-manufacturing","kind":"technology","name":"Viral vector manufacturing (lentiviral, retroviral, AAV)","aka":[],"tldr":"Producing the engineered viruses that carry a CAR gene into T cells. Viral vector manufacturing is a long-standing bottleneck for cell and gene therapy.","summary":"Lentiviral vectors for CAR-T are made by transient transfection of HEK293 cells with plasmid DNA, or increasingly by stable producer cell lines; AAV serves in vivo gene therapy. Capacity shortages in 2018-2022 delayed trials; large CDMOs (Lonza, Thermo Fisher, Charles River, Oxford Biomedica) and in-house plants (Kite, Novartis, BMS) have since expanded. Titre, empty-capsid ratio, and cost per dose are the quality and economic levers.","status":"established","asOf":"2026-09-08","links":[{"label":"FDA guidance: chemistry, manufacturing and control information for human gene therapy INDs","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["cell-therapy","drug-discovery"],"technologies":["car-t","plasmid-dna-manufacturing"],"targets":[],"drugs":[],"companies":["lonza","oxford-biomedica","thermo-fisher","charles-river"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":["plasmid-dna-manufacturing"],"notes":[],"principle":"Packaging and transfer plasmids co-transfected into producer cells; harvested particles are purified by chromatography and tested for titre, potency, and replication competence.","strengths":["Mature quality systems","Stable producer lines lowering cost"],"limitations":["Long lead times and high cost","Batch variability","Plasmid supply dependency"]},"route":"/technologies/viral-vector-manufacturing/","neighbours":{"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"},{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"technology":[{"id":"allogeneic-cell-banks","kind":"technology","name":"Allogeneic cell banks: one donor, hundreds of doses","route":"/technologies/allogeneic-cell-banks/"},{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"oncolytic-virus","kind":"technology","name":"Oncolytic viruses","route":"/technologies/oncolytic-virus/"},{"id":"plasmid-dna-manufacturing","kind":"technology","name":"Plasmid DNA and mRNA raw-material manufacturing","route":"/technologies/plasmid-dna-manufacturing/"},{"id":"single-use-bioprocessing","kind":"technology","name":"Single-use bioprocessing systems","route":"/technologies/single-use-bioprocessing/"},{"id":"tcr-t","kind":"technology","name":"TCR-T cell therapy","route":"/technologies/tcr-t/"}],"company":[{"id":"catalent","kind":"company","name":"Catalent (Novo Holdings)","route":"/companies/catalent/"},{"id":"charles-river","kind":"company","name":"Charles River Laboratories","route":"/companies/charles-river/"},{"id":"cytiva","kind":"company","name":"Cytiva (Danaher)","route":"/companies/cytiva/"},{"id":"lonza","kind":"company","name":"Lonza","route":"/companies/lonza/"},{"id":"oxford-biomedica","kind":"company","name":"OXB (Oxford Biomedica)","route":"/companies/oxford-biomedica/"},{"id":"takara-bio","kind":"company","name":"Takara Bio","route":"/companies/takara-bio/"},{"id":"thermo-fisher","kind":"company","name":"Thermo Fisher Scientific","route":"/companies/thermo-fisher/"}],"term":[{"id":"cdmo","kind":"term","name":"CDMO (contract development and manufacturing organisation)","route":"/terms/cdmo/"}]}}