CMC Issues are a Leading Cause of Cell & Gene Therapies Clinical Holds

Published: 21-Jan-2025 Featured companies: Solvias AG
Manufacturing Regulatory Research & Development

Overcoming CMC challenges to accelerate cell and gene therapy approvals

CGT trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over six months. Potency assay challenges are a major contributing factor. Download our latest white papers and webinar recording to uncover strategies for optimizing cell-based bioassay development and accelerating your path to approval.

Access the resources here: https://eu1.hubs.ly/H0ftZWT0

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Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on our...
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Solvias opens Center of Excellence for Biologics and Cell and Gene Therapy

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The facility will bring approximately 200 new jobs to the area over the next three years and is being rolled out in two phases

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