Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing: To date, the FDA has approved 36 cell and gene therapy products (1). In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There are now six FDA approved commercially available CAR-T products (2) and the development of cell therapies is continuing to gather pac

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Published inBiopharm international Vol. 37; no. 7; p. 14
Main Authors Cashen, Paul, Deckers, Susanne, Ladi, Rukmini
Format Magazine Article
LanguageEnglish
Published Intellisphere, LLC 01.07.2024
Subjects
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Audience Trade
Author Ladi, Rukmini
Cashen, Paul
Deckers, Susanne
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StartPage 14
SubjectTerms Antigens
Drug approval
Gene therapy
Genes
Immunotherapy
T cells
Title Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing: To date, the FDA has approved 36 cell and gene therapy products (1). In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There are now six FDA approved commercially available CAR-T products (2) and the development of cell therapies is continuing to gather pac
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