MANUFACTURING ARTICLES
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide 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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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA 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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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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2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA Therapeutics
As 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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A New Space Race: Reclaiming Efficiency In The mRNA Industry
It 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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In Vivo's Biggest Threat — Comparison To Old Models
In 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Find out how to achieve reliable IVT mRNA quality. Learn the best practices for precise analysis, including proper sample prep and system optimization for high-resolution results.
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This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
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Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.
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Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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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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CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.