RNA Manufacturing

MANUFACTURING ARTICLES

Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes Next
Oligonucleotide therapies have proven clinical value, but scaling beyond rare disease remains hard. William Soliman, Ph.D., BCMAS, breaks down the manufacturing, delivery, and CMC realities shaping what comes next.
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026
Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter
Now, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing
Here, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy
In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.

MANUFACTURING VIDEOS

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Purification Of DNA Oligonucleotides Using AEX Chromatography Webcast

Explore impurities removed by strong anion exchange chromatography for the advancement of these molecules as therapeutics and a cost-effective, efficient, and scalable purification method.

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Major Trends In Next-Gen RNA Engineering: Audience Q&A

We end each Cell & Gene Live by answering our audience’s questions in real time. Here, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics provide detailed responses to questions regarding managing manufacturing, scalability, and more.

Chromatography And Column-Free Processes

Listen in on a discussion surrounding questions about chromatography and column-free processes in the development of mRNA vaccines and therapeutics.

Novel Excipients Versus Active Substances And Inflammatory Response

Novel excipients or active substances? In this segment of Risk Reduction In mRNA Therapeutic Development, we address the debate and discuss LNP-related inflammatory response concerns.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

Extending The Lower Limits Of Quantification Of A Therapeutic Oligonucleotide Through Microflow LC-MS/MS

Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.
How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential

Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.
Bringing Allogeneic Cell Therapy To Patient Care

Bringing allogeneic cell therapy to patient care will require flexible, closed, and automated solutions to support the treatment options and increasing scale of the industry.
Advancing A LNP Formulation To Clinical And Commercial Manufacturing

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 Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy

We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
Key Insights Into Overcoming mRNA Process Challenges

Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.

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