MANUFACTURING ARTICLES
-
![business challenge, risk-GettyImages-2200659695]( "Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter")
Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next ChapterNow, 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.
-
![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference give 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.”
-
![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn 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.
-
![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "What You Should Know About USP's Bioassay Updates")
What You Should Know About USP's Bioassay UpdatesThe United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
-
![vacation-GettyImages-1430503053]( "New Group Wants 'Phase-Appropriate' Thinking To Retire")
New Group Wants 'Phase-Appropriate' Thinking To RetireDecisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.
-
![Creative problem solving, skill, solution-GettyImages-2184276582]( "The Case for Process Simplification in mRNA Manufacturing")
The Case for Process Simplification in mRNA ManufacturingHere, 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.
MANUFACTURING VIDEOS
Listen in on a discussion reviewing key drivers behind the flurry of activity in mRNA therapeutic development and begin to address the rate-limiting risks to mRNA therapeutic development.
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.
Peptones can significantly boost CHO cell bioprocessing. We analyze their impact on diverse CHO cell lines using real-world data to assess their effects on titer, protein quality, and cell growth.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1355122387 RNA]( "Single-Step Purification Of A 21-mer Oligonucleotide Using Capto™ Q ImpRes Resin")
Explore how the oligonucleotide therapeutics market is advancing with scalable solutions for high-purity purification, supporting global production of life-changing RNA therapies.
-
![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Getting CMC Right For Emerging Technologies")
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
-
![mRNA GettyImages-1356994684]( "mRNA Manufacturing And Formulation")
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
-
![Molecule]( "mRNA-LNP Nucleic Acid Assessment From Distinct Formulations")
Review a showcase of a high throughput robust analysis for nucleic acid integrity and size assessment of mRNA-LNP samples using a multi-capillary system and purity and integrity analysis kit.
-
![DNA molecules 450x300]( "Data Processing For Mass Confirmation, Impurities Analysis Of Oligos")
Explore an automated, compliance-ready LC-MS workflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including siRNA and large single guide RNA oligonucleotides.
-
![Multivariate Inter-Stage Batch Profile Monitoring Feature]( "Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation")
How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?
-
![mRNA GettyImages-1356994684]( "Best Practices For Analysis Of IVT mRNA")
Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
