MANUFACTURING ARTICLES
-
To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
-
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
This study demonstrates an optimized cooling protocol for cryopreserving large-volume cryovials in a controlled-rate freezer, avoiding the need for liquid nitrogen.
-
Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.
-
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
-
Unlock the full potential of CRISPR-Cas9 gene editing with high-purity Cas9 mRNA, the emerging choice for safer and more efficient genome engineering.
-
RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.
-
To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this scale-up process brings challenges that must be addressed.
-
We show CRISPR/Cas9-mediated knockouts of the T cell receptor and explore multi-step LNP engineering to produce TCRɑβ KO CAR T cells, a promising approach towards allogeneic CAR T cell therapy.