Featured Editorial
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Developing Bespoke Antisense Oligonucleotides To Treat Rare Diseases
11/26/2024
EveryONE Medicines CEO, Kent Rogers, explains the company’s mission to address a major unmet need in children with rare neurodegenerative diseases, one patient at a time.
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Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact
11/26/2024
The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?
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RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology
11/19/2024
During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
11/19/2024
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
11/18/2024
Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.
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RNA Therapeutics: New Market Research
11/14/2024
According to our new market research, the RNA therapeutics industry is predicted to exceed $31 billion by 2032. This article shares key findings and trends.
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Were We (Are We) Correct About Oligonucleotides?
11/12/2024
In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.
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Emerging Partnership Trends In Oligo-Based Medicines
11/6/2024
The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.
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Lessons From The Past: How mRNA Can Thrive In The Evolving ATMP Market
11/4/2024
Fortunately, as multiple presenters during the AGC CDMO Summit explained, there have been a few historical case studies of how the industries preceding us did (or didn’t quite) do the due-diligence they should have to trigger meaningful societal change. Not only do these case studies provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.
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Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
10/28/2024
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.