ANALYTICAL/QUALITY ARTICLES

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

ANALYTICAL/QUALITY VIDEOS

In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.

Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.

Axxium uncovered hidden peptide aggregation using MMS technology, revealing process-related potency issues missed by conventional methods. Learn how advanced structural analysis can strengthen quality control and biologics development.

Watch this rundown of a novel method for quantifying L-Citrulline, L-Arginine, and L-Argininosuccinic acid using Mitra tip extraction coupled with LC-MS/MS for enhanced accuracy and reproducibility.

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