Newsletter | May 10, 2025

05.10.25 -- Cell & Gene Best Of April

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Discover the future of iPSC-based therapies in this free Cell & Gene Live digital event. Experts will share insights on emerging applications, regulatory challenges, gene editing advancements, and key safety considerations in scalable iPSC manufacturing. Don't miss this opportunity to hear from leaders at the forefront of regenerative medicine. Supported by Invetech.

FROM THE EDITOR

Hello Cell & Gene readers,

 

I'm happy to bring you April's most-clicked articles. Enjoy!

 

Erin Harris, editor-in-chief  
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APRIL'S BEST FEATURED EDITORIAL

Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials

Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why

The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

Alternatives To Testing Sterility In Cell- And Tissue-Based Products

Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

APRIL'S BEST INDUSTRY INSIGHTS

Small Volume ATMP Cryo-Freezing Strategies

Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.

Understanding Potency In Gene Therapy Development

Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.

A Driving Force For Advanced Cleanroom Standards

Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

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