pISSN 2234-3806eISSN 2234-3814
Table. 1.
Challenges faced during CGT product manufacturing that may affect their clinical use
| Type of therapy | Type of cell or vector | Points to consider during the manufacturing process |
|---|---|---|
| Cell-based therapy | MSCs |
Quality of the tissue source (starting material) Duration of cell cultivation Presence of residual xenogeneic serum |
| Gene-based therapy | AAV | Separation of empty from full AAV capsids |
| LV |
Presence of residual impurities (including xenogeneic serum) Optimization of transfection conditions Development of (a) stable producer cell line(s) |
|
| Cell-based gene therapy | CAR-T cells |
Quality of leukapheresis material Impurities Complex, multistep procedures |
Abbreviations: CGT, cell and gene therapy; MSCs, mesenchymal stem cells; AAV, adeno-associated virus; LV, lentiviral vector; CAR-T, chimeric antigen receptor T.
Ann Lab Med 2024;44:314~323 https://doi.org/10.3343/alm.2023.0382
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