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

Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.

Discover a compact, fully automated oligonucleotide synthesizer for robust, scalable process development. Learn how it can help establish a robust and reproducible oligo synthesis process.

Explore an overview of the development and scale-up activities needed to develop high quality lipid nanoparticles and progress this saRNA vaccine to the clinic.

During this first segment of Cell & Gene Live, Major Trends in Next-Gen RNA Engineering, hosted by Cell & Gene’s Chief Editor, Erin Harris, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics discuss the two major trends developing in the next generation RNA space. They cover how to more accurately target tissues to reduce off-target effects or to cross a therapeutic threshold for protein expression. In addition, they discussed how to improve the amount, quality, and longevity of expressed protein to expand the use cases for RNA.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS