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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Analyzing Poly(A) Tails Of In Vitro Transcribed RNA
Find out how to achieve reliable IVT mRNA quality. Learn the best practices for precise analysis, including proper sample prep and system optimization for high-resolution results.
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Limiting Off-Target Effects Of CRISPR-Based Products
Find out how to enhance CRISPR gene editing specificity by using Next Generation Sequencing to improve sgRNA quality control, addressing off-target effects and ensuring higher sequence fidelity.
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Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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The Art Of Phosphitylation
Phosphorylation is key for bioactives, with phosphoramidites favored for high selectivity. Discover how choosing specific protecting groups and new technologies fine-tunes the synthesis process.
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Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio
CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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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.
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Establishing Analytical Methods For mRNA-Based Therapies
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.