Newsletter | January 10, 2024

01.10.24 -- CQAs For mRNA/LNPs: Current & Future Considerations


Understanding CQAs For mRNA/LNP Development And Manufacture

BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.

5 Leadership Learnings In Preventative Cancer Vaccine Development

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.


Establishing Analytical Methods For mRNA-Based Therapies

Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

Defining A Process For Your Unique mRNA

Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.

High-Velocity Development: Gene Therapy vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.