Featured Editorial
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From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing Partnerships
7/24/2024
In the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.
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A "Hot Take" On mRNA Critical Process Parameters
7/17/2024
Bushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production.
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In Vivo Genetic Medicines Need a Guide: The Answer Lies in Harnessing the Transcriptome
7/15/2024
This article by Radar Therapeutics explains why the DNA/RNA revolution is underway and why solving specific targeting is next.
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End-To-End mRNA DS And DP Manufacturing Processes
7/10/2024
This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.
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Innovation Advances In mRNA Medicine
7/9/2024
The post-pandemic mRNA pipeline surge has led to a substantial investment in innovation. Let’s look at nonamplifying mRNA, saRNA, and circRNA.
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Making Cancer Vaccines Is Complex; New Platform Guidance Could Help
7/3/2024
FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.
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CRISPR-Cas Genome Editing For Rejuvenation Of Aging Stem Cells
7/1/2024
As stem cells age, their regenerative capacity declines due to accumulated genetic and epigenetic changes. Using CRISPR-Cas, scientists can directly edit these changes or modulate aging-related pathways.
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A "Hot Take" on Personalized mRNA Medicines
6/20/2024
mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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What Does FDA's Draft Platform Guidance Mean For CGT Companies?
6/17/2024
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
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Do You Know Your QMM? Moderna Might Some Day
6/17/2024
Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.