MANUFACTURING ARTICLES
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![biotechnology, Global Networking, Research, Development, Innovation, Advancing Smart Solutions-GettyImages-2123154659]( "Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control")
Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle ControlOligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "The mRNA Supply Chain Revolution: Materials, Methods, And Momentum")
The mRNA Supply Chain Revolution: Materials, Methods, And MomentummRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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![genetic research, biotechnology, molecular biology, innovation, healthcare solutions-GettyImages-2234236209]( "A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?")
A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
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![Scientist virus research laboratory-GettyImages-1493597834]( "2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA Therapeutics")
2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA TherapeuticsAs RNA therapeutics mature, 2026 will reward execution over novelty. Delivery, data-driven design, and modality specialization will determine which RNA platforms scale clinically and commercially.
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![Vector Retro Astronaut Team Exploring a Planet on a Jetpack-GettyImages-2186580479]( "A New Space Race: Reclaiming Efficiency In The mRNA Industry")
A New Space Race: Reclaiming Efficiency In The mRNA IndustryIt goes without saying that efficiency in drug development is tantamount — especially when it comes to getting much-needed clinical data. So, when I asked Allan Shaw about the ongoing trends he anticipates seeing more of in 2026, he immediately pointed to the increasing prominence of overseas development, particularly in nations like Australia and China.
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![caution, precision-GettyImages-2149261776]( "In Vivo's Biggest Threat — Comparison To Old Models")
In Vivo's Biggest Threat — Comparison To Old ModelsIn vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
MANUFACTURING VIDEOS
Looking to enhance performance and manufacturing from your DNA backbone without the regulatory concerns? Gain advantages over legacy plasmid DNA backbones and minicircles.
Watch to learn when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for various drug products.
Join our webinar on scaling the CTS LV-MAX System in bioreactors, covering transfection scalability, Thermo S.U.B. advantages, and DynaSpin’s efficient gene therapy integration.
Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![protein bio-synthesis GettyImages-1355122387]( "A Plasmid DNA Purification Process For A Variety Of Therapies")
Guidance for your plasmid DNA downstream process development, exploring cell harvest, lysis, neutralization and clarification; chromatographic purification; TFF; and sterile filtration unit operations.
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![Gett images-542576580 bio]( "Top 5 Approaches To The Bioanalysis Of Oligonucleotides")
Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.
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![Advancing RNA_Primrose Scientific Poster Melanie Venter]( "Advancing mRNA Therapeutics With High Performance RNA Polymerases")
Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.
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![GettyImages-919410014-dna-gene-therapy-future-technology]( "Purification Of DNA Oligonucleotides Using An Anion Exchange Resin")
Learn how a strong anion exchange resin can be used for the efficient purification of single-stranded DNA oligonucleotides used in clinical trials.
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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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![GettyImages-2215842270 lab]( "Charged For Action: The Hidden Secrets Of AEX Oligonucleotide Analysis")
Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.
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![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
