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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Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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Discover how mRNA technologies open the doors to a whole range of new gene therapies and the role of lipid nanoparticles (LNPs) in current and future developments.
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Unlock the full potential of CRISPR-Cas9 gene editing with high-purity Cas9 mRNA, the emerging choice for safer and more efficient genome engineering.
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Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.
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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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Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.