FORMULATION ARTICLES

• Translating An Early-Stage mRNA Therapeutic Into The Clinic

  In the following Q&A, Ethris CMO Thomas Langenickel shares some of his biggest questions and observations about the evolving mRNA therapeutics space that are the most impactful in translating early-stage RNA candidates into the clinic — particularly when that drug product boasts a novel formulation.

• Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics

  Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

• Is The mRNA Payload The Real MVP of Targeted Delivery?

  As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery. 

• Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics

  Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.

• Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation

  Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.

• IP Considerations For Early-Stage mRNA Therapeutics Development

  Fortunately, navigating the patent landscape is hardly a “doomsday” scenario. But it is a challenge biotechs need to tackle early so they don’t end up too far down the path toward the clinic or in the clinic mired with delays and expensive litigation. Here, Rothwell Figg partner Dan Shores shares several strategies companies may choose to employ when facing a legal gray area to protect their products from patent litigation upon commercialization.