Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?

Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future. 

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. 

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.

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.

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.

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.

Future-Proofing mRNA Drug Manufacturing: The Value of Continuous Improvement

With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.

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.

Twist Of Two: 2D-LC For Oligos

Discover how coupling orthogonal mechanisms reveals hidden impurities and creates a more robust strategy for characterizing complex oligonucleotide samples.

Best Practices For Analysis Of IVT mRNA

Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.

mRNA Product Purification Process Strategies

Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.

Quality Control Of Oligonucleotides Using HPLC Coupled To UV And MS Detection

Efficient quality control of therapeutic oligonucleotides is crucial. Explore advanced methods combining HPLC-UV and mass spectrometry for precise impurity quantification and mass confirmation.

Stick With Me: The Cool Chemistry Of HILIC Oligonucleotide Analysis

Discover a powerful alternative for analyzing polar sequences without ion-pairing reagents. By leveraging hydrophilic partitioning, you can achieve sharper separation and improved mass spectrometry compatibility.