Aldevron Breakthrough Blog / Max Sellman

Eureca-Vᵀᴹ: What is it?

Meet a new catalog CRISPR protein

If you were at the Advanced Therapies Week in Miami from January 17-20, you learned first-hand about our newest catalog CRISPR protein, Eureca-V™ Nuclease. But what exactly is Eureca-V? In short, the core technology for Eureca-V is the proprietary MAD7® nuclease developed by Inscripta®. Aldevron and Inscripta have partnered to make this protein broadly available to the therapeutic, diagnostic, and agricultural research markets. 

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Fast Advances Highlight CRISPR 2.0

A focus on personalized therapeutics

Genomic medicine field has progressed in leaps and bounds these last few years, and at the 3rd Annual CRISPR 2.0 conference, it was wonderful to again connect in person with colleagues to discuss those advances. It was a great opportunity to listen and learn from a prestigious lineup of gene editing experts from across the industry.

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Novel Stem Cell Therapies

A first look at patient data at ISSCR

I’m always grateful for the chance to hear the latest results from drug developers in the CRISPR space. That’s why it was a huge bonus to have a world class cell and gene therapy conference just fifteen minutes down the road from Aldevron Madison in September!

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Connecting on CRISPR

Innovation from the CRISPR 2022 Meeting

When it comes to gene editing technology, there are few meetings as valuable for us and our collaborators as the annual CRISPR meeting. Academic in focus and highly technical in nature, the 2022 edition of this event came to Boston, packing more than 40 lectures and 120 posters into a rapid-fire, three-day learning experience.

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How New FDA Guidelines Can Affect Cell Therapy Development, part 2

The effect on autologous and allogeneic therapies projects

In my previous post on new draft FDA guidelines that concern cell therapies, I covered key control considerations for CRISPR reagents and the GMP manufacturing considerations for drug substances affected by that guidance. In this post, I’ll go over a couple approaches to consider when working with gene-modified cell therapies, and how they could be affected.

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How New FDA Guidelines Can Affect Cell Therapy Development, Part 1

Defining control considerations for CRISPR reagents is key

The FDA recently released draft guidance on Investigational New Drug (IND) applications for Human Gene Therapy Drug Products Incorporating Human Genome Editing technology to edit human somatic cells. This much-anticipated draft highlights manufacturing, quality, and regulatory considerations for drug developers preparing IND filings for novel, gene-modified cell therapies.

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