READ: ARW ON RNA

  1. A "Hot Take" On mRNA Critical Process Parameters 7/17/2024

    Bushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production.

  2. 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. 

  3. A "Hot Take" on Personalized mRNA Medicines 6/20/2024

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

  4. 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.

  5. Multidisciplinary mRNA: What Can We Learn From Other CGTs? 5/20/2024

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

  6. 2 “Must-Haves” In mRNA CDMO Outsourcing Partnerships 5/13/2024

    In the final installment of this two-part series, Jain shares his assessment of the partnering landscape for mRNA therapeutic candidates. Though capacity has been a hot-button topic/need for other modalities in the ATMP space, his tips for evaluating CDMOs for mRNA therapeutics keep us aligned around the importance of capability and flexibility in outsourcing partnerships, especially when working with a nascent therapeutic modality.

  7. "A Particular Set Of Skills:" Outsourcing Considerations For mRNA Therapeutics 5/6/2024

    In the first of this two-part article series, Jain offers us his observations on the growth of the mRNA outsourcing sector, as well as the most important learnings he’s gleaned from engaging and contracting CDMOs in this space — particularly in these “earlier” days of the RNA therapeutics industry.

  8. “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).

  9. “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.

  10. 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.