A practical guide to fit-for-purpose analytical development in an emerging cell therapy landscape

A panel of experienced professionals in cell therapy analytical development address day-to-day challenges in product development in a cell therapy landscape where both the cell types and the analytical tools used to characterize them are constantly evolving. The panel offers practical advice on how to navigate a changing regulatory landscape, as well as how to leverage the cutting edge in technological advancements for optimized product characterization and quality control.

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Publication Details

Journal
Cell and Gene Therapy Insights
Published
2025-06-18
DOI
https://doi.org/10.18609/cgti.2025.070
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
0.00
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article

A practical guide to fit-for-purpose analytical development in an emerging cell therapy landscape

Jie Wei, David A. Marshall, Florian Durst
Cell and Gene Therapy Insights
CAR-T cell therapy research
article

A practical guide to fit-for-purpose analytical development in an emerging cell therapy landscape

Jie Wei, David A. Marshall, Florian Durst
article en

Abstract

A panel of experienced professionals in cell therapy analytical development address day-to-day challenges in product development in a cell therapy landscape where both the cell types and the analytical tools used to characterize them are constantly evolving. The panel offers practical advice on how to navigate a changing regulatory landscape, as well as how to leverage the cutting edge in technological advancements for optimized product characterization and quality control.

Cell and Gene Therapy InsightsVol. 11(5)
Resolve Therapeutics (United States) (US), RPX (United States) (US), Thermo Fisher Scientific (Germany) (DE)
Openalex Percentile: Top 44%
CAR-T cell therapy research
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