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- W3193955231 abstract "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." @default.
- W3193955231 created "2021-08-30" @default.
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- W3193955231 creator A5051098144 @default.
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- W3193955231 creator A5074225402 @default.
- W3193955231 date "2021-08-23" @default.
- W3193955231 modified "2023-09-26" @default.
- W3193955231 title "Formulation Considerations for Autologous T Cell Drug Products" @default.
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- W3193955231 doi "https://doi.org/10.3390/pharmaceutics13081317" @default.
- W3193955231 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/8400304" @default.
- W3193955231 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34452278" @default.
- W3193955231 hasPublicationYear "2021" @default.
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