Newsletter | August 19, 2026

08.19.26 -- 5 Critical Regulatory Topics To Watch In The Oligo Sector

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FEATURED EDITORIAL

5 Critical Regulatory Topics To Watch In The Oligo Sector

Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.

Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process Productivity

Explore how anion exchange chromatography improves oligonucleotide purification through smarter resin design, better separation, and scalable manufacturing.

Patenting Therapies In The Age Of AI: What Companies Must Get Right Early

As AI transforms RNA discovery, companies must rethink inventorship, obviousness, and patent strategy to secure durable intellectual property protection.

A European Executive's Guide To Entering The U.S. RNA Market

A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.

Reassessing Nanoparticle Immunotoxicity Approaches New And Old

This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies.

INDUSTRY INSIGHTS

What Is Holding Back Your Cleaning Validation From Compliance?

Inadequate facility monitoring leads to severe regulatory delays. Learn how integrated stakeholder planning, rigorous testing, and solid documentation protect your plant operations.

Defining LNP Formulation Parameters For Scale-Up Success

Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

The Bioanalysis Report You Actually Get Back Fast

Manual assay variability compromises regulatory filings. Discover how automated workflows replace human error with repeatable processes to boost data precision and audit readiness    .

Mapping End-To-End Cryopreservation In Cell-Gene Logistics

Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.

Why RNA Diversity Is Raising The Bar For Platform-Aware IVT Design

Diverse RNA modalities demand custom transcription workflows. Examine why platform-aware IVT design is essential for optimizing stability across increasingly complex therapeutic payloads    .

Benchmarking 2D-LC/MS Strategies For Oligo Impurity Profiles

Low-level coeluting variants disrupt quality control. See how high-resolution sampling, 2D-LC/MS, and automation work together to deliver deeper characterization of complex impurities    .

The Economic Case For Continuous Manufacturing

Traditional batch production drags down therapeutic margins. Explore how continuous manufacturing platform models utilize real-time analytics to slash timelines, costs, and risks    .

What Is Preventing Optimal IVT Yields In Large-Scale mRNA?

Suboptimal in vitro transcription compromises RNA stability and yield. Uncover critical parameter adjustments needed to optimize reaction conditions for commercial mRNA manufacturing    .

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