ANALYTICAL/QUALITY ARTICLES
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Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter
Now, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
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The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
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
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
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
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
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma
This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.
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CRISPR Off-Target Editing: Prediction, Analysis, And More
A crucial consideration for researchers is off-target editing – unintended DNA modifications at sites other than the intended target. Explore the complexities and strategies to mitigate these effects.
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Quantification Of Large Oligonucleotides Using High Resolution MS/MS
Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.
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The Absolute Essentials Of Manufacturability
Learn why integrating Quality by Design (QbD) and Process Analytical Technology (PAT) early on is essential for developing a robust, controlled, and financially viable process.
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Expression Analysis Of CTLA-4, PD-1, And PD-L1
Advance personalized immunotherapy in NSCLC by leveraging qPCR-based analysis of CTLA-4, PD-1, and PD-L1 expression to identify predictive biomarkers and guide more effective treatment strategies.
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Study Viral Infection In Resting Human CD4+ T Cells
Explore a study proving how synthetic single guide RNAs were used to optimize the editing conditions for resting human CD4+ T cells and maintain high cell viability for several weeks post Nucleofection.
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Large Scale Purification Of Oligonucleotides With IEX
As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.