Newsletter | May 3, 2024

05.03.24 -- Cell & Gene Best Of April


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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When Does GMP Matter In Non-GMP Settings?

Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

Shocking! Biotech Facilities Don't Maintain Themselves

Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times.


An End-To-End Industrialization Roadmap For Autologous Cell Therapy

Explore specificities and challenges, leveraging automation for scalability with the Cocoon Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.

mRNA/saRNA Manufacturing RNA Production And Manufacturing

Venkata Indurthi, Ph.D., shares insights about the development, validation, and manufacture of messenger RNA and self-amplifying RNA, and tailoring processes to meet unique requirements.

Overcoming Challenges In AAV And LV Viral Vector Manufacturing

Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.


Expertly Navigating The Regulatory Landscape Together

Supply Chain Challenges For Cell & Gene

Capacity Update February 2024: Cell & Gene

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