Formulation Considerations for Autologous T Cell Drug Products
Genetically modified autologous T cells have become an established immunotherapy in the fight against cancer. The manufacture of chimeric antigen receptor (CAR) and αβ-T cell receptor (TCR) transduced T cells poses unique challenges, including the formulation, cryopreservation and fill–finish steps,...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-08-01
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| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/13/8/1317 |
| _version_ | 1797522365311090688 |
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| author | Christopher F. van der Walle Sonya Godbert Gabriele Saito Zein Azhari |
| author_facet | Christopher F. van der Walle Sonya Godbert Gabriele Saito Zein Azhari |
| author_sort | Christopher F. van der Walle |
| collection | DOAJ |
| description | Genetically modified autologous T cells have become an established immunotherapy in the fight against cancer. The manufacture of chimeric antigen receptor (CAR) and αβ-T cell receptor (TCR) transduced T cells poses unique challenges, including the formulation, cryopreservation and fill–finish steps, which are the focus of this review. With an increasing number of marketing approvals for CAR-T cell therapies, comparison of their formulation design and presentation for administration can be made. These differences will be discussed alongside the emergence of automated formulation and fill-finish processes, the formulation design space, Monte Carlo simulation applied to risk analysis, primary container selection, freezing profiles and thaw and the use of dimethyl sulfoxide and alternative solvents/excipients as cryopreservation agents. The review will conclude with a discussion of the pharmaceutical solutions required to meet the simplification of manufacture and flexibility in dosage form for clinical treatment. |
| first_indexed | 2024-03-10T08:28:24Z |
| format | Article |
| id | doaj.art-7e281b717721464ab41da4ccbe753743 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T08:28:24Z |
| publishDate | 2021-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-7e281b717721464ab41da4ccbe7537432023-11-22T09:16:01ZengMDPI AGPharmaceutics1999-49232021-08-01138131710.3390/pharmaceutics13081317Formulation Considerations for Autologous T Cell Drug ProductsChristopher F. van der Walle0Sonya Godbert1Gabriele Saito2Zein Azhari3GSK R&D, Gunnels Wood, Stevenage, Herts SG1 2NY, UKGSK R&D, Gunnels Wood, Stevenage, Herts SG1 2NY, UKGSK R&D, Gunnels Wood, Stevenage, Herts SG1 2NY, UKGSK R&D, Gunnels Wood, Stevenage, Herts SG1 2NY, UKGenetically modified autologous T cells have become an established immunotherapy in the fight against cancer. The manufacture of chimeric antigen receptor (CAR) and αβ-T cell receptor (TCR) transduced T cells poses unique challenges, including the formulation, cryopreservation and fill–finish steps, which are the focus of this review. With an increasing number of marketing approvals for CAR-T cell therapies, comparison of their formulation design and presentation for administration can be made. These differences will be discussed alongside the emergence of automated formulation and fill-finish processes, the formulation design space, Monte Carlo simulation applied to risk analysis, primary container selection, freezing profiles and thaw and the use of dimethyl sulfoxide and alternative solvents/excipients as cryopreservation agents. The review will conclude with a discussion of the pharmaceutical solutions required to meet the simplification of manufacture and flexibility in dosage form for clinical treatment.https://www.mdpi.com/1999-4923/13/8/1317closed processfill–finishdesign spaceprimary containercryopreservationfreeze–thaw |
| spellingShingle | Christopher F. van der Walle Sonya Godbert Gabriele Saito Zein Azhari Formulation Considerations for Autologous T Cell Drug Products Pharmaceutics closed process fill–finish design space primary container cryopreservation freeze–thaw |
| title | Formulation Considerations for Autologous T Cell Drug Products |
| title_full | Formulation Considerations for Autologous T Cell Drug Products |
| title_fullStr | Formulation Considerations for Autologous T Cell Drug Products |
| title_full_unstemmed | Formulation Considerations for Autologous T Cell Drug Products |
| title_short | Formulation Considerations for Autologous T Cell Drug Products |
| title_sort | formulation considerations for autologous t cell drug products |
| topic | closed process fill–finish design space primary container cryopreservation freeze–thaw |
| url | https://www.mdpi.com/1999-4923/13/8/1317 |
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