Aldevron Breakthrough Blog

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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When Preparation Meets Opportunity

mRNA’s rise amidst the COVID pandemic

The introduction of mRNA vaccines by Pfizer and Moderna for COVID-19 took much of the world by surprise. But for Katalin Karikó, Pieter Cullis, and Drew Weissman, among others, it was merely the culmination of decades of research and development. Implementing a novel modality during such a public health crisis took confidence, determination, and the hard work of millions of people. It didn’t happen overnight.

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Why Apply ISO 13485 Principles in a Protein Manufacturing Facility?

A stepping-stone in ongoing quality improvement

The ISO 13485 standard covers the quality management system (QMS) requirements for medical devices (like CT scanners, blood perfusion pumps, diagnostic IVD tests) including requirements for regulatory purposes. Certification is granted by a third-party registrar through an annual audit process with renewal every three years. Unlike global medical device governmental regulations, the ISO 13485 standard is the same whether you are manufacturing in Italy, Africa or the United States.
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A Maturing Market

Expectations, oversight and transparency

From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.

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Expanding an Analytical Framework

Increased expectations, increased accountability

Rapid evolution. In short, that’s what we’re seeing in the method development and assay life cycle field. The concepts have been around for quite some time, but now with updated and new guidance for analytical life cycle and analytical method development, we’re seeing a more dynamic period emerging in the space. This includes increased expectations for analytical method development and increased accountability for reporting development data.

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Looking back at 2022

Four events that made it a great year

I must admit, I’m a sucker for just about any list article. Show me a title such as, “8 Reasons Why…” or “10 Movies That…”, and there’s a pretty good chance I’ll click. I often find myself scrolling through the strangest lists, reviewing things that I really don’t care about – kitchen gadgets, closet organizing products, stocking stuffers. I’m hopeless. I’m compelled to click.

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Eliminate Protein and Antibiotic Markers

Advantages of the Nanoplasmid RNA-OUT Marker System

For decades, the same plasmid technology has been used in vaccination, cell and gene therapy, and as a raw material in viral vector and RNA production, but that technology often isn’t a good fit for the processes where it’s being used. Now, with the growing availability of Nanoplasmid™ vectors, that is changing.

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The Power of Small

Whitepaper showcases next-generation plasmid technology

NanoplasmidTM. We’ve been discussing this topic quite a bit recently, and now our latest whitepaper brings you an in-depth examination of our novel Next-Generation plasmid technology. The etiology of its name, “nano,” originates from its purposefully designed “small” backbone of around 500 base pairs (bp) as compared to traditional plasmids that often exceed 2000 bp. This reduced backbone size is a direct result of removing prokaryotic and antibiotic-resistance genes used to select transformed bacteria and propagate a vector.

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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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