RNA Manufacturing Articles

  1. 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.

  2. Assessing pDNA Purity For Cell & Gene Therapies 5/1/2024

    Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.

  3. mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention 4/26/2024

    mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.

  4. “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA 4/24/2024

    It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

  5. “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.

  6. A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers 4/19/2024

    Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.

  7. 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.

  8. ARW's ATMP Manufacturing Must-Reads (ECLIPSE EDITION!) 4/11/2024

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

  9. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

  10. Navigating Grades And Sources Of Materials In Drug Manufacturing 3/22/2024

    From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.