Featured Editorial

1. 5 Leadership Learnings In Preventative Cancer Vaccine Development 12/6/2023

   Calviri has been developing an RNA vaccine to prevent cancer for more than 20 years and repeatedly faced the nearly universal belief that it’s impossible. We’ve learned a number of important lessons along the way that are worth imparting to other vaccine developers.

2. The RNA Therapeutics Race: How Can Pharma Stay Ahead Of The Wave? 12/5/2023

   With more than 970 RNA therapies currently in the development pipeline, the market presents an exciting prospect. This article shares the key attributes of RNA therapies that are paving the way for personalized medicine, novel delivery mechanisms, and more.

3. Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms 11/28/2023

   Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.

4. 6 PEG Alternatives You Should Be Thinking About 11/22/2023

   PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.

5. Achieving Flexibility In RNA Drug Manufacturing With Microfluidics 11/21/2023

   RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.

6. Modular And Single-use Tech Driving The Future Of Biomanufacturing 11/14/2023

   BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.

7. What We Need To Unlock Next-Generation mRNA Therapeutics 11/13/2023

   mRNA is an incredibly nimble platform for drug discovery and development, but in order to truly unlock the next generation of mRNA therapeutics, we need to think outside the box (and we also need more funding).

8. What Regenerative Medicine Manufacturers Have Been Waiting For 11/9/2023

   It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.

9. New Developments In mRNA Vaccine Efficacy Show Promise 11/1/2023

   Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.

10. 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.