Newsletter | June 14, 2025

06.14.25 -- Cell & Gene Best Of May

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With pressure to both accelerate development and prioritize robustness, CGT companies often have limited time for refining manufacturing, analytics, and logistics. Enter the Cell & Gene Therapy Tech Expo: a dynamic slate of industry-leading suppliers showcasing the latest in solutions across Cell Therapy, Gene Therapy, and GMP/Regulatory Compliance via 15-minute interactive presentations. Register for free and make continuous improvement a reality on your path to scalability, cost reduction and, ultimately, enhanced patient access.

FROM THE EDITOR

Hello Cell & Gene readers,

 

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

 

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

Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing support and resources that empower it to thrive in its objectives and endeavors.

A Case For Paying Allogeneic Cell Therapy Product Donors

The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

Distributed Cell Therapy Manufacturing Trade-Offs You Should Know About

For all its patient-centered benefits, producing personalized medicine at the point of care has pitfalls that are worth careful consideration.

MAY'S BEST INDUSTRY INSIGHTS

Gene Therapy Assays: Regulatory Compliance With Unified Immunogenicity

Explore the complexities of immunogenicity assessment in gene therapy development that focuses on regulatory frameworks in the US and EU, and gain insight into the best practices for global compliance.

Multi-Regional Clinical Trials: The Latest Guidance From FDA

Conducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.

Ask The Expert: 21 CFR Part 11 Compliance

Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical and medical device companies with implementing solutions and systems to ensure compliance.

MAY'S BEST SOLUTIONS

Comprehensive CMC-QC Solutions For Cell Therapy

Low Endotoxin Products For Critical Environments

The Unique Challenges Of The Cell & Gene Therapy Supply Chain

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