MANUFACTURING ARTICLES
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![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.
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![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 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.”
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![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.
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![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.
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![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.
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![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
In this snippet, panelist Alex Aust (with the help of several live attendee commenters) tackles a particularly tricky question: Are our outsourcing partnerships producing high quality products today, and what are the most common root causes of batch failures?
In this segment of the Bioprocess Online Live event mRNA Manufacturing: Bright Future, Big Challenges, we get to know leaders at three organizations bringing mRNA technology to bear in a variety of prophylactic and therapeutic capacities. Tune in and get to know Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx.
Learn about the different applications that filter plates can be used for, and see how they can improve laboratory workflows. Additonally, explore a portfolio of high-performance filter plates.
As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cell Culture Media Filtration]( "Cell Culture Media Filtration: Evaluating Cell Culture Performance")
Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.
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![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.
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Learn more about oligo workflows and solutions for oligonucleotide process development, from scalable oligo synthesis to cleavage and deprotection, purification, and buffer exchange.
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![scientist iStock-1166567091]( "mRNA Transfection Reagent Enhances Non-Viral Gene Delivery To Stem Cells")
Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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![GettyImages-648181930-viral-development-vaccine-lab]( "mRNA/saRNA Manufacturing - RNA Therapeutic Delivery And Applications")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including insight into RNA delivery and the applications–present and future–that innovations in the field are enabling.
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![GettyImages-1311518492-vaccine-vial]( "Expanding Into New Fields Of “Cell-Grow-Culture” For mRNA Transfection")
Learn about one path forward to navigate the pitfalls with mRNA transfection and a medium to assist in lentivirus-mediated transduction of human mesenchymal stromal/stem cells (hMSCs).
