RNA Formulation 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. “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.

3. 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.

4. 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.

5. RNA Vaccines: Just Scratching The Surface 12/28/2023

   RNA vaccines have shown promise in preventing infectious diseases and treating cancer, but clinical development varies markedly between the two. HDT Bio’s Dr. Berglund discusses this and how they can be improved.

6. How To Break RNA’s “4-Minute Mile” 12/20/2023

   Four CEOs provide their take on some of the hot topics of discussion in the RNA therapeutics space. Whether they be homing in on platform development, much-needed scientific advancements, or commercialization considerations, each of these experts’ quotes speaks to the important “training efforts” we should be building into our “workout” regimens to condition our companies and our products to achieve (and surpass!) RNA’s own “four-minute mile(s).”

7. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

   The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

8. Defining The RNA Therapeutics Industry In 2023 1/16/2023

   Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

9. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

   To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.

10. The Expanding Patent Landscape For RNA-Based Therapeutics 11/16/2022

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.