Newsletter | June 7, 2024

06.07.24 -- Cell & Gene Best Of May


With additional cell therapy approvals on the horizon, a diverse array of products and platforms are needed to ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall COGS. Join Cell & Gene Live for a digital discussion on the next generation of platforms and innovative technologies. Registration is free thanks to the support of Invetech.


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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CGT: An Overview Of FDA Regulatory Considerations For 2024

Here, the authors outline key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.

Inside BlueRock Therapeutics' Parkinson's Disease Trial

BlueRock Therapeutics' SVP Head of Development, Dr. Ahmed Enayetallah discusses the company's phase 1 clinical trial for Parkinson’s disease, which continues to show positive trends at 18 months.

Developing A PPQMP For Gene Therapies

This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.


A CDMO's Checklist For Prospective Clients: Part 1

Ever wondered about the flip side of client-CDMO dynamics? In this series, discover why transparency is vital for both parties in a fruitful partnership.

Cell Therapy Milestones, Challenges, And Forming The Future Of TILs

What enabled the evolution of TIL therapies? What does the future hold for them? And where should you concentrate your efforts to accelerate progress? Watch for answers to these questions and more.

CMC And Quality Considerations When Engaging Your CDMO

Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.


Cell And Gene Therapies – Changing The Healthcare Landscape

Cell And Gene Therapy Solutions

Enhanced T Cell Expansion While Maintaining Early Memory Cell Phenotype

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