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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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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Assessing Doggybone DNA For In Vitro Transcription
In this study, we evaluated the performance of two dbDNA IVT templates, each encoding the same mRNA (firefly luciferase or Fluc), by looking at the mRNA purity and in vivo potency of the mRNA IVT’d from each template.
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Why Bioanalysis Needs To Break Free From Manual Bottlenecks
Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.
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Understanding The Intricacies Of qMSI
Explore quantitative mass spectrometry imaging (QMSI) and leading spatial bioanalysis and biology services that offers one-on-one support throughout your drug development process.
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Precision In Nanoparticle Processing And Monodispersed Lipid Nanoparticles For Advanced Therapeutics
Precision in nanoparticle processing is key for drug delivery and vaccines. Learn how monodispersed formulations enhance reproducibility and stability for next-generation therapeutics, like RNA-LNPs.
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RNA: The Next Era In Therapeutic Development
Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.
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Comparing Real-Time And Digital PCR Technologies
Which PCR technologies are the most effective? Compare digital PCR (dPCR) and real-time or quantitative PCR (qPCR) to determine the best choice for your labs.