MANUFACTURING ARTICLES

• Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter

  Now, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance. 

• Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing

  Here, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.” 

• From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

  In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

• What You Should Know About USP's Bioassay Updates

  The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

• New Group Wants 'Phase-Appropriate' Thinking To Retire

  Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

• The Case for Process Simplification in mRNA Manufacturing

  Here, I wanted to share a few additional details from Parrella’s presentation about the efforts he and his team at Kernal Biologics made to improve their overall mRNA-LNP COGS. Though he emphasized the amount of opportunity that exists to improve our utilization of costly raw materials/reagents, as he revealed, there are also opportunities for process simplification.