Newsletter | October 14, 2026

10.14.26 -- What Oligo Manufacturing Risks Are We Underestimating?

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CDMO Services: Customized Lipids & LNP Solutions

Bringing your lipid-based therapies from early research into clinical and commercial manufacturing demands more than technical capability. It requires experience, flexibility, and seamless execution across development stages. Explore GMP-ready, fully connected CDMO services: From lipid manufacturing through LNP formulation, manufacturing, and Fill & Finish. In this infographic, you will discover flexible collaboration models tailored to your path, pace, and evolving program needs. Download now to learn more!

FEATURED EDITORIAL

What Oligo Manufacturing Risks Are We Underestimating?

Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos. 

Will 2027 See A Meteoric Rise Of Programmable Nanomedicine?

The significance of programmable nanomedicines is not simply that nanoparticles can carry more functions. It is that biological information can become part of the control logic.

AI Agents Are Only As Good As The RNA Knowledge Behind Them

The RNA field is producing extraordinary volumes of information. Yet, giving an AI system access to more information does not necessarily make the system more scientifically intelligent.

Bridging The Gap Between Analytical Control & Translation

Though we may have increasingly clear understandings of our mRNA-LNP products structurally, understanding our products’ cellular function remains challenging without extensive clinical data. Here, this Advancing RNA panel featuring AbbVie’s Elaine Peters, Tessera’s Ilya Shestopalov, and Sanofi’s Philippe Talaga addresses what innovation — both in research and method development — can help us get more functional information about our molecules as we wait for more clinical development.  

INDUSTRY INSIGHTS

The Fast Track To Global Expansion: Consistency Across Every Site

Operational consistency across global facilities protects product integrity and supports growth. Standardized processes reduce risk, minimize variability, and strengthen quality across markets.

Nucleic Acid-LNP Ultrafiltration And Diafiltration

Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.

Minimizing Volume Requirements, Turnaround Time For Compendial Testing

Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.

Establishing Analytical Methods For Emerging mRNA-Based Therapies

Verifying quality attributes requires precise analytical tools. Explore methods evaluating both mRNA drug substances and finished drug products to secure therapeutic profile.

The Evolution Of Nucleotide Production

From harsh chemicals to gentle enzymes: discover the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.

De-Risking Early mRNA Constructs For Future cGMP Manufacturing

Uncover the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

Comprehensive Characterization Of Oligonucleotides And Related Impurities

A two-dimensional LC/MS strategy improves the separation of coeluting oligonucleotide impurities. High-resolution sampling and automation enable deeper characterization of low-level variants.

Enhancing Gene Editing Outcomes And Safety for Clinical Translation

Vector backbone design directly impacts expression durability. Examine how streamlined vector architecture boosts safety and editing efficiency during clinical translation.

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Webinar: Connecting the World of Oligonucleotide R&D With Early Clinical Scale Manufacturing

Moving oligonucleotide production from R&D to early clinical manufacturing brings new challenges in quality, scalability, process development, and equipment. This webinar explores a requirements-driven approach to oligonucleotide manufacturing, from solid-phase synthesis through scale-up, and highlights advances in synthesizer technology. Gain practical insights into building robust, reproducible processes that support pharmaceutical development and manufacturing at clinical scale. Click here to learn more.

SOLUTIONS

Systems For Lipid Nanoparticle (LNP) Production

Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis

Meet The Latest Member Of The Oligo Synthesis Family