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Considerations for manufacturing of cell and gene medicines for clinical development

3 Dec 2024

Abstract excerpt

The global changes from 2001 that elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst for the dramatic expansion of the field to its current and future commercial success. Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC), which led to the development of the term "advanced...

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PMID: 39797851
DOI: 10.1016/j.jcyt.2024.11.015

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