MANUFACTURING ARTICLES
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![Pharmaceutical factory-GettyImages-186614852]( "The Evolution Of Oligonucleotide Manufacturing: Engineering Considerations For Scale, Efficiency, And Facility Design")
The Evolution Of Oligonucleotide Manufacturing: Engineering Considerations For Scale, Efficiency, And Facility DesignAs oligos move toward larger indications, manufacturing shifts from chemistry alone to facility design—balancing scale, solvent safety, cost, and flexibility as SPOS, slurry, and enzymatic paths converge.
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![Investment in medical and pharma business GettyImages-1299804755]( "2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends")
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture TrendsAs RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
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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.
MANUFACTURING VIDEOS
Speaking of outsourcing, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share what they’re manufacturing in house, what they’re outsourcing, and why in this segment from our recent CMC, Scale Up, & The Road To mRNA Regulatory Approval event.
In this opening Advancing RNA Live clip, NanoVation Therapeutics’ Dominik Witzigmann and Stealth Co’s John Zuris share the scientific advancements they’ve been watching most keenly in the LNP space, as well as some of the evolutions they’re seeing in the overall quality of our RNA-LNP products.
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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![mRNA GettyImages-1356994684]( "Freezing mRNA: Best Practice")
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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![Cytiva-602047-1. Accelerating the Development]( "Accelerating The Development And Scale-Up Of mRNA Vaccines")
Learn how downstream considerations can make the difference between success and failure on the path towards the commercialization of mRNA vaccines.
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![GettyImages-1317300897 Abstract 3d polygonal DNA molecule]( "Contrast In Oligonucleotides")
Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.
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![GettyImages-1026593952 tablet, data]( "Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up Optimization")
Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.
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Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance.
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![DNA molecules 450x300]( "Purifying Plasmid DNA Using A Modern Chromatography Resin")
Through an industry collaboration, Cobra and Cytiva were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.
