Newsletter | September 14, 2024

09.14.24 -- Cell & Gene Best Of August

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The supply chain for mRNA-based cell and gene therapies presents unique challenges due to the sensitive nature of these products. Join Cell & Gene Live on September 24th for a digital discussion on how the industry can improve the efficiency, reliability, and scalability of the supply chain for mRNA-based therapies. Registration is free thanks to the support of Roche CustomBiotech.

FROM THE EDITOR

Hello Cell & Gene readers,

 

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

 

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

How CSL Behring And EMA/FDA Developed Hemgenix Potency Assays

Gene therapy products are complicated, and it can be hard to know at which step to measure potency. Here's how CSL Behring did it for Hemgenix.

Bacterial Endotoxin Testing, Part 1: Overview

Injectable drugs and implantable devices in contact with blood or spinal fluid are tested for endotoxins. This article reviews bacterial endotoxin testing and the LAL method.

CGT Regulatory Update And Outlook With Kimberly Benton, Ph.D.

Dark Horse Consulting Group joins Erin Harris to discuss Biologics License Applications (BLAs) of recent approvals and those currently under review.

AUGUST'S BEST INDUSTRY INSIGHTS

A CDMO's Checklist For Prospective Clients: Part 2

In Part 2 of our series, we delve deeper into the crucial elements of transparency that prospective clients should consider when partnering with a CDMO, including analytics, documentation, and more.

Identifying The Right Analytical Strategy For AAV Production

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

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