RNA Manufacturing Articles

  1. IP Considerations For Early-Stage mRNA Therapeutics Development 2/7/2025

    Fortunately, navigating the patent landscape is hardly a “doomsday” scenario. But it is a challenge biotechs need to tackle early so they don’t end up too far down the path toward the clinic or in the clinic mired with delays and expensive litigation. Here, Rothwell Figg partner Dan Shores shares several strategies companies may choose to employ when facing a legal gray area to protect their products from patent litigation upon commercialization.

  2. A Primer On The RNA Patent Landscape 1/31/2025

    In the first- of this three-part article, Shores gives us an important primer on the RNA legal landscape as it stands today. As many of us are working on crafting the next generation of mRNA/RNA products and LNPs, I wanted to get his sense of how our continued scientific advancement is likely to impact the IP landscape in the long-term.

  3. mRNA Empowering Engineered In Vivo Cell Therapies 1/21/2025

    Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.

  4. Top 5 mRNA/RNA Advancements of 2024 (Part 2) 12/30/2024

    As I took stock of the year behind us, there were five overarching ways in which I saw our industry taking steps forward and finding itself on sturdier scientific and clinical footing. Here, in the second of this two-part article, I continue down this list with my last three takeaways.

  5. Go From Batch To Continuous RNA Purification With mAb Equipment And QBD 12/30/2024

    University of Sheffield researchers developed a novel method purify polyadenylated mRNA continuously, which stands to improve productivity and efficiency.

  6. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

  7. RNase Control: An Overview With Market Trends 12/2/2024

    This article shares an overview of ribonuclease (RNase) control and some associated macro market research.

  8. Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact 11/26/2024

    The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?

  9. RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology 11/19/2024

    During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.

  10. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

    The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.