Newsletter | July 10, 2024

07.10.24 -- A "Hot Take" On Personalized mRNA Medicines


Addressing the most prominent pain points of speed, cost of production and limited flexibility, the mRNA Process Development & Manufacturing Summit returns to Boston this September. Hear from 30+ technical experts from the likes of Moderna, BioNTech, Sanofi and Strand Therapeutics across three days of content spanning tracks dedicated to Research Scale and IND-Enabling & Clinical Scale production. See program here.


A "Hot Take" On Personalized mRNA Medicines

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.

Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products

FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

In Which Specific Areas Do mRNA Makers Need More Regulatory Guidance?

Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.


Mechanisms Of LNP-Mediated mRNA Delivery

Explore the details supporting LNP-mediated mRNA delivery, as well as the challenges facing mRNA based therapeutics in the future.

How inSeption Unlocked The Secret To Repeatable, Scalable Low Turnover

This case study explores the evolution of a 10-year partnership and extrapolates the principles that create cohesive teams and minimize turnover.

Future Proof Your Process Scale Workflow

Discover how you can future-proof your process scale workflow, from starting bases to tangential flow filtration.

Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy

RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.