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Updated: Feb 27, 2026

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

細胞・遺伝子治療における化学・製造・管理（CMC）のための相関分析の応用

Sangwook Choi¹, Alan Y Chiang², Catherine Cheng³

¹Biostatistics, Cell Therapy Development and Operations, Bristol Myers Squibb, Seattle, WA, USA.

Journal of biopharmaceutical statistics

|February 26, 2026

Abstract:

Correlative analysis is widely used in drug product development and manufacturing to explore the potential associations between attributes of interest. The manufacturing and control of cell and gene therapy (CGT) products are often affected by multiple factors, such as limited knowledge of product characteristics, variable starting materials, complex manufacturing and limited manufacturing experience. Understanding of correlations among process, product and clinical outcome parameters can support process optimization and improve product quality. In this paper, we review the applications of correlative analysis and discuss their implications in CGT product development and manufacturing. We also discuss the unique challenges associated with performing correlative analysis in CGT. Finally, we provide a summary of statistical techniques commonly used to identify associations among attributes related to Chemistry, Manufacturing and Controls (CMC) and clinical outcome. This review aims to provide insights into the effective use of correlative analysis to enhance the development and manufacturing of CGT products.

キーワード:

化学・製造・管理（CMC）相関分析自家CAR T細胞療法細胞・遺伝子治療（CGT）

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