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
Three Advancing RNA Live panelists share their greatest needs in outsourcing partnerships for mRNA/RNA-LNP products and where sponsors should be the most prescriptive when drafting an MSA with an outsourcing partner.
Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.
Learn how to choose the best filtration device for your specific application and understand pore size, membrane material, well volumes and tip types.
BioNTech’s Ben Muir shares a high-level overview of the LNP preclinical research advances that are the most exciting/promising today — while also reminding us of a few important caveats that accompany early-stage research.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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).
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![GettyImages-1097343012 lab, production, manufacturing, bioprocessing]( "Production And Clarification Of Lentiviral Vectors")
Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.
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We are trying to simplify freezing and thawing protocols, basing them on biology and physics, and it is important to define these final steps to reduce wasting time, effort, and money. Delve into the science of cell thawing.
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![GettyImages-1443323134-digital-binary-code-artifical-intelligence-robotic-hand]( "Digital Twins And Mechanistic Models For Optimized Bioprocessing")
Integrating AI and having a robust IT infrastructure is crucial for modernizing your processes. Discover how digital twins and mechanistic modeling are revolutionizing biomanufacturing, enhancing efficiency, and reducing costs.
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![iStock-178131492-lab-research-beaker]( "Extending The Lower Limits Of Quantification Of A Therapeutic Oligonucleotide Through Microflow LC-MS/MS")
Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.
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![Genomic DNA GettyImages-1311197612]( "Flexibility And High-Quality Extraction Of Genomic DNA And RNA From Yeast, Saccharomyces Cerevisiae")
In this report, we analyze the quality and quantity of gDNA as well as RNA from S. cerevisiae with Pall NAB Nanosep centrifugal devices in comparison with a renowned commercial brand.
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![Treatment with Nanoparticles Genetic therapy GettyImages-805434264]( "Process Development Considerations For RNA-LNP Therapeutics")
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
