MANUFACTURING ARTICLES
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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.
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![Vector Retro Astronaut Team Exploring a Planet on a Jetpack-GettyImages-2186580479]( "A New Space Race: Reclaiming Efficiency In The mRNA Industry")
A New Space Race: Reclaiming Efficiency In The mRNA IndustryIt 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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![caution, precision-GettyImages-2149261776]( "In Vivo's Biggest Threat — Comparison To Old Models")
In Vivo's Biggest Threat — Comparison To Old ModelsIn 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.
MANUFACTURING VIDEOS
High Throughput Screening (HTS) chromatography tools can accelerate process development and reduce material usage. Learn about a solution that addresses challenges with their use in new modalities.
Unlock the power of data-driven bioprocessing. Discover how advanced analytics can optimize your cell culture process, improve performance, and accelerate success.
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
Optimize mRNA development by learning key strategies for process refinement, critical component identification, and in-process analytics to enhance therapeutic production.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1371707479-lab-mask-team-partnership]( "mRNA/saRNA Manufacturing RNA Program Development & Support")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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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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![GettyImages-1354923731-magnifying-glass-mrna]( "IVT mRNA Encapsulation Efficiency Assessment")
In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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![MilliporeSigma Feature]( "Streamlining Biomanufacturing Automation With Connectivity And Integration")
Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.
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![Multivariate Inter-Stage Batch Profile Monitoring Feature]( "Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation")
How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Developing A Scalable RNA-LNP Drug Product For Clinical Translation")
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
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![Treatment with Nanoparticles Genetic therapy GettyImages-805434264]( "Process Development Considerations For RNA-LNP Therapeutics")
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
