Newsletter | July 5, 2024

07.05.24 -- Cell & Gene Best Of June


Hello Cell & Gene readers,


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


Erin Harris, editor-in-chief 
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Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of CGT Products

FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

New Guide Tackles Best Practices For Making Allogeneic Cell Therapies

The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

Top Strategies To Reduce Off-Target Effects For Safer Genome Editing

Genome editing holds immense promise for treating genetic diseases, but off-target effects remain a significant concern resulting in the development of various strategies to reduce those risks.


How Do CGT Requirements Differ Between FDA And EMA?

Examine the similarities and differences between how the FDA and EMA approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

Improving Access And Support For Cell And Gene Therapies

Although cell and gene therapies are potentially transformative, their effectiveness is undermined by difficulties with patient access and support, high costs, and a complex pathway to treatment.

A Beginner's Guide To Cell Therapy Bioprocessing

Take a deeper look into innovative solutions for researchers facing challenges throughout the development of novel cell and gene therapeutics.


Sonexus Access And Patient Support: Aiding Patients At Every Step

A New Horizon In AAV cGMP Gene Therapy Manufacturing

WuXi Advanced Therapies Philadelphia Campus Overview

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