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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Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins. They enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.
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An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
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Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
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Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.
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This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.