# Viral vector manufacturing (lentiviral, retroviral, AAV)

Source: https://onco.cc/technologies/viral-vector-manufacturing/  
OnCo record `viral-vector-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- FDA guidance: chemistry, manufacturing and control information for human gene therapy INDs: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/), [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)
- technologies: [Allogeneic cell banks: one donor, hundreds of doses](https://onco.cc/technologies/allogeneic-cell-banks/), [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-NK & CAR-macrophage](https://onco.cc/technologies/car-nk-macrophage/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Oncolytic viruses](https://onco.cc/technologies/oncolytic-virus/), [Plasmid DNA and mRNA raw-material manufacturing](https://onco.cc/technologies/plasmid-dna-manufacturing/), [Single-use bioprocessing systems](https://onco.cc/technologies/single-use-bioprocessing/), [TCR-T cell therapy](https://onco.cc/technologies/tcr-t/)
- companies: [Catalent (Novo Holdings)](https://onco.cc/companies/catalent/), [Charles River Laboratories](https://onco.cc/companies/charles-river/), [Cytiva (Danaher)](https://onco.cc/companies/cytiva/), [Lonza](https://onco.cc/companies/lonza/), [OXB (Oxford Biomedica)](https://onco.cc/companies/oxford-biomedica/), [Takara Bio](https://onco.cc/companies/takara-bio/), [Thermo Fisher Scientific](https://onco.cc/companies/thermo-fisher/)
- terms: [CDMO (contract development and manufacturing organisation)](https://onco.cc/terms/cdmo/)

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