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
In this segment of a recent Bioprocess Online Live! panel discussion, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus address a rapid cadence of audience questions.
The Ignite with NxGen Technology embodies everything that made the NanoAssemblr Platform the go-to for nanomedicine development for over 200 biopharma companies, while bringing the latest innovations developed for the cGMP system to the bench — saving time and money.
Watch this rundown of a novel method for quantifying L-Citrulline, L-Arginine, and L-Argininosuccinic acid using Mitra tip extraction coupled with LC-MS/MS for enhanced accuracy and reproducibility.
Here, Advancing RNA Live speakers Khaled Yamout, Sanofi’s Francoise Ribes, and Camp4’s Satya Kuchimanchi share which supply chain advancements they would like to see in the near future, as well as how they anticipate these changes & evolutions could impact each modality’s growth.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1076055404 chromatography, purification]( "The Secret To Pure Oligos: Why Anion Exchange Chromatography Rules At Scale")
Discover how anion exchange chromatography delivers high loading capacity and clinical-grade purity while addressing common scale-up challenges like aggregation and equipment longevity.
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![GettyImages-2190246741 lab]( "Phase-Appropriate Approaches To Manufacturing And Testing")
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "mRNA Vaccines And Therapeutics: Current Trends And Perspectives")
Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.
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![Implementing Continued Process Verification Feature]( "How To Automate Continued Process Verification")
This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Discussing mRNA: Challenges And Opportunities For Scale-Out And Optimization")
In a recent Cell & Gene Live event, experts explored challenges surrounding raw materials – both quality and supply – as well as the importance of achieving more efficient scale-out and turnaround times for mRNA production.
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![cell-gene-therapy-GettyImages-2157300524]( "Safe, Scalable And GMP-Ready DNA")
Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Key Stages In mRNA-Based Therapeutic Development")
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
