RNA Formulation Articles

  1. A "Flight Plan" For Achieving These 3 mRNA Development Milestones 10/18/2024

    Here, in the final installment of this three-part series, I’ll share the panelists’ greatest learning experiences and regulatory advice (so far) on what we should be looking out for as we strive to achieve three big milestones: Entering the clinic; implementing advanced manufacturing technologies into our processes; and standardizing our manufacturing platforms.

  2. Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At Night 8/9/2024

    It goes without saying that there’s a lot we need to understand about how our drug products’ composition (i.e., lipid/mRNA ratio) analytical profile, and manufacturing process impact their potency and safety. But I also appreciated the panels’ focus on the importance of gaining a clearer understanding of the biological factors that influence the strength, durability, immunogenicity, and overall deliverability of our RNA therapeutics in vivo.

  3. Collaboration Key To Going "Out On A Limb" For Nonviral mRNA Delivery 7/31/2024

    As the members of this panel at the World Vaccine Congress emphasized, they see great — and in some cases untapped — opportunities for collaboration to better advance nonviral delivery of a wide variety of RNA therapeutics. 

  4. Two "Hot Takes" On mRNA Delivery 7/2/2024

    As I argued in a previous “Hot Take,” “the devil is in the details” when it comes to developing both our drug substances and our drug products. We need to get to the point where we have more details and knowledge about alternative methods of delivery (beyond LNPs) so we can make educated decisions on the best path forward for delivering our products. 

  5. A "Hot Take" On mRNA Scale-Up 6/12/2024

    In the following multi-part “mini-series” of RNA industry “Hot Takes,” I share several aspects that jumped out at me from the BioPhorum ATMP Event — starting with several takeaways about mRNA scale-up.

  6. Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing 5/29/2024

    Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

  7. Forum Notebook: Quick Takes From USP's mRNA Virtual Summit 5/1/2024

    The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.

  8. “Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] Space 4/19/2024

     

    In the first- of this two-part article, Koeris and I ford through some of the most prominent delivery-vehicle development pain-points that don’t get nearly as much conversation as they should today. Though Koeris did not sugarcoat his concerns with some of our current mRNA delivery/LNP development limitations, the questions he posed and considerations he offered give us clearer direction around where we must pursue more scientific “heroism” in the mRNA space.

  9. Unpacking The Importance Of Lipid Nanoparticle Production Platforms 4/15/2024

    Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

  10. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.