Featured Editorial
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The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies
8/28/2025
The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
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Translating An Early-Stage mRNA Therapeutic Into The Clinic
8/26/2025
In the following Q&A, Ethris CMO Thomas Langenickel shares some of his biggest questions and observations about the evolving mRNA therapeutics space that are the most impactful in translating early-stage RNA candidates into the clinic — particularly when that drug product boasts a novel formulation.
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The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
8/20/2025
There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
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Oligos Step Into The Spotlight: A Growing Force In Genetic Medicine
8/18/2025
Oligonucleotide therapeutics are experiencing a new wave of momentum. As the science evolves and the market opportunity expands, the landscape is poised for continued growth and diversification.
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Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing
8/13/2025
Overall, there were three main takeaways I gleaned from our conversation that suggest the oligo sector, though more established than its mRNA cousin, is not comfortable with the status quo and is actively trying to grow beyond the limits of its current manufacturing paradigm. Here in part 1, we’ll start with my number one takeaway, which also comes equipped with a bit of history as to how we find ourselves at our current juncture.
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Inside Arbor Biotech's In Vivo Gene Therapy Approach
8/6/2025
Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.
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5 Takeaways From The MHRA mRNA Guidance
7/28/2025
Having read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA.
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All Of Us Need To Be Rooting For The FDA
7/23/2025
In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.
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Ancient Molecule, Modern Medicine: The Science, Strategy, & Stakeholders Behind tRNA Therapeutics
7/22/2025
As we all know well, “unearthing” our molecules’ potential poses numerous technical and business-related challenges for young biotech companies. Here, Werner and I continue our conversation, unpacking some of these internal and external challenges the company is navigating as it strives to bring tRNA to the commercial market.
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Tales From The Trenches: Developing Potency Assays Outside Big Pharma
7/18/2025
Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.