Scaling Challenges in Cell and Gene Therapy Highlight Need for Advanced Manufacturing Strategies

The transition from clinical development to commercial production in cell and gene therapy (CGT) faces challenges related to manufacturing scalability. Industry experts have identified key priorities for overcoming these limitations, emphasizing the importance of efficient strategies to ensure therapies reach patients without delays or disruptions.

Manufacturing bottlenecks often hinder the progression of CGT from research stages to widespread availability. Addressing these issues requires a focus on scaling production processes while maintaining quality and compliance standards. Strategies proposed include streamlining workflows, integrating advanced technologies, and optimizing regulatory frameworks to support large-scale manufacturing. These measures aim to facilitate the delivery of life-changing therapies by bridging gaps between clinical trials and commercial distribution effectively.

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Source: GO-AI-ne1

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Date: November 26, 2025

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