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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Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
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Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Learn how ultrafiltration devices in various steps of the cloning workflow can provide a more streamlined process compared to traditional methods of subcloning PCR-generated fragments.
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Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation optimization to cryopreservation techniques.
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By following some of the best practices in freezing mRNA, you can effectively balance product quality, cost-effectiveness, process safety, and efficiency.
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Learn how purpose-driven decisions backed by a thorough process that reaps you the largest profit potential over time can result in successful scale up.