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
By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.
Novel excipients or active substances? In this segment of Risk Reduction In mRNA Therapeutic Development, we address the debate and discuss LNP-related inflammatory response concerns.
Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants?
Built on our revolutionary NxGen™ technology found in our NanoAssemblr® family of instruments, NanoAssemblr® GMP System enables you to go from concept to clinic with speed and confidence.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![RNA abbreviation of ribonucleic acid-GettyImages-1453953422]( "Exploring Osmolality As A CQA Within RNA Therapeutics")
Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation optimization to cryopreservation techniques.
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![Molecule mRNA-GettyImages-1428646288]( "Optimized Performance Model For Yield And Quality Of The mRNA Product")
Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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![SUS app note image]( "The Chilled Future Of mRNA Filling And Freezing")
Manufacturers at biotech and biopharma companies need help keeping up with continuously advancing novel treatments. Technologies that provide control over the freeze-thaw process offer solutions.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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![GettyImages-958260280-genetic-engineering-genome-editing-helix-dna]( "Genome Editing of Human Primary T Cells With Lipid Nanoparticles")
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.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
