MANUFACTURING ARTICLES
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
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![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
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![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
MANUFACTURING VIDEOS
We discuss key components and common pain points of scaling up nanomedicine production and use recent publications to walk customers through the process.
As Pfizer and Moderna publicly announce work on an mRNA-based universal flu vaccine, what else is on the horizon for mRNA? Tune in to this segment from the Bioprocess Online Live event mRNA Manufacturing: Bright Future, Big Challenges for a discussion with 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. In this clip, they share market forecasts for mRNA vaccines and therapeutics and their companies’ go-forward plans to meet those demands.
Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities.
The emergence of RNA-encapsulated-lipid nanoparticles has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2165310987-chromosome-nucleotide-gene]( "Research-Scale Oligonucleotide Workflow")
Get a clear view of oligonucleotide development from synthesis to purification and filtration with practical insights to help you streamline workflows and stay ahead in the fight against disease.
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![Sartorius CIM HIP Plasmid Process PackTM, CIMac pDNA]( "In-Process Control Of pDNA Production On CIMac™ pDNA Analytical Column")
As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
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.
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![Sartorius]( "Talent And Supply: Building A Foundation For The Future Of Biopharma")
Read how to create future-ready facilities supported by advanced scientific knowledge and a secure supply chain that can handle the unprecedented demands and constraints of a post-COVID world.
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![Precision NanoSystems Feature]( "Understanding The Microfluidic Platforms For Scaling Nanoparticle Production")
Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
