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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Top 5 Approaches To The Bioanalysis Of Oligonucleotides
Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.
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Detection Of Adapter Dimers In NGS Libraries
Accurately identifying low‑level adapter dimers is key. Compare electrophoresis methods to show how different kits detect and resolve small fragments, helping researchers choose the best QC approach.
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The Value Of Peptones For Enhancing Biopharmaceutical Productivity
Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
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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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Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows
Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.
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Engineered Enzymes Powering The Future Of mRNA Therapeutics
Optimizing RNA polymerase selection significantly improves mRNA yield and purity while reducing dsRNA. Discover how advanced enzyme engineering enhances therapeutic manufacturing efficiency and safety.
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Suitability Testing For IVT mRNA Analysis
Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.