Perspectives on quality, compliance, and innovation to accelerate CGT manufacturing

“...the integration of automation, standardized protocols, evolving regulatory frameworks, and robust scale-up strategies will be critical...” Lauren Coyle, Editor, BioInsights, speaks to Hélène Negre, Pharmaceutical Affairs Director, CELLforCURE, about the manufacturing of ATMPs and how they are undergoing rapid transformations, driven by the need for speed, safety, and scalability. The article shares insights on key challenges in batch release, the importance of cross-functional collaboration, and innovations shaping the future of CGT manufacturing.

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Publication Details

Journal
Cell and Gene Therapy Insights
Published
2025-09-19
DOI
https://doi.org/10.18609/cgti.2025.117
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.00
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article

Perspectives on quality, compliance, and innovation to accelerate CGT manufacturing

Cell and Gene Therapy Insights
Biosimilars and Bioanalytical Methods
article

Perspectives on quality, compliance, and innovation to accelerate CGT manufacturing

article en

Abstract

“...the integration of automation, standardized protocols, evolving regulatory frameworks, and robust scale-up strategies will be critical...” Lauren Coyle, Editor, BioInsights, speaks to Hélène Negre, Pharmaceutical Affairs Director, CELLforCURE, about the manufacturing of ATMPs and how they are undergoing rapid transformations, driven by the need for speed, safety, and scalability. The article shares insights on key challenges in batch release, the importance of cross-functional collaboration, and innovations shaping the future of CGT manufacturing.

Cell and Gene Therapy InsightsVol. 11(8)
LFB (France) (FR)
Industry, innovation and infrastructure
Openalex Percentile: Top 38%
Biosimilars and Bioanalytical Methods
DOIOpen Access PDFOpenAlex
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Perspectives on quality, compliance, and innovation to accelerate CGT manufacturing · Cell and Gene Therapy Insights (2025) | TGRS Research Map | TGRS