ANALYTICAL/QUALITY ARTICLES
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Stay "Stereocurious": What The Future Holds For Oligo Quality
Overall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
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Order, Chaos, And The mRNA Black Box: Takeaways From The USP/AMM Forum
To be clear, this year’s USP/AMM quality forum was just as focused on the intricacies of applying/using the methods. But what was equally if not more present in this year’s discussion was our increasing acknowledgement that our understanding of mRNA and its biological mechanisms remains quite messy.
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From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics
Guide RNA is evolving from a simple targeting reagent into a complex, engineered molecule shaped by expanding CRISPR modalities, increasing length and modification demands, and tighter integration with manufacturability, analytical control, and regulatory expectations.
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The RNA Ties That Bind: 3 Takeaways From The OPT Congress
Here, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.
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Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
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MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug Discovery
Realizing the therapeutic potential of miRNAs in liver disease requires confronting a problem the field has not fully reckoned with.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Unlocking The IP Benefits Of Novel Nucleases In CRISPR Therapies
Incorporating novel nucleases into CRISPR therapies enhances intellectual property benefits through improved licensing, strategic protections, and access to new gene targets.
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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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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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Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification
Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.
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Demystifying CRISPR gRNA Chemical Modifications
Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.
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Mastering mRNA Manufacturing: A Focus on Raw Materials & Supply Assurance
Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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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.