MANUFACTURING ARTICLES

  • Is mRNA Manufacturing Overbuilt?

    mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

  • 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. 

  • RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation

    From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance. 

  • What Baby KJ Taught Us About mRNA COGS

    Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”

  • Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics

    RNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.

  • A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products

    NIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.

MANUFACTURING VIDEOS

In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.

In this Advancing RNA Live clip, CPI’s Claire MacCleod shares the biological and logistical hurdles currently keeping full enzymatic production of siRNA at bay. 

In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery for Strand Therapeutics, outline several examples of foundational research that could provide insights into how we attain more specific cellular uptake of LNPs.

Unlock next-generation nanoparticle and LNP manufacturing. Achieve high throughput, minimal waste, and superior quality with a compact, automated, and contamination-controlled system.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS