MANUFACTURING ARTICLES
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![Virus, microscopy, vaccine, covid-GettyImages-1439691672]( "Engineering Transient In Vivo CAR-T: Extending Expression, Expanding Access, And Rethinking Immune Reset")
Engineering Transient In Vivo CAR-T: Extending Expression, Expanding Access, And Rethinking Immune ResetIn this Q&A, Michael Lam, Ph.D., explores how circular RNA and targeted delivery extend transient CAR expression to enable deep B-cell depletion and controllable immune reset.
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![Pipetting samples-GettyImages-525440703]( "Bridging The Manufacturing Chemistries Between Drug Research And Development For Morpholino Oligos")
Bridging The Manufacturing Chemistries Between Drug Research And Development For Morpholino OligosStandardizing Morpholino chemistry could streamline development and FDA pathways, improving consistency, scalability, and delivery performance across antisense therapeutics.
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![genetic engineering and gene manipulation, CRISPR technology, genome editing, molecular biotechnology, genetic science research, gene therapy-GettyImages-2196575232]( "From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics")
From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR TherapeuticsGuide RNA is evolving from a simple targeting reagent into a complex, engineered molecule shaped by expanding CRISPR modalities, increasing length and modification demands, and tighter integration with manufacturability, analytical control, and regulatory expectations.
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![DNA Helix, Futuristic Digital Interface, genetics, molecular biology, gene editing-GettyImages-2221747428]( "A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA Synthesis")
A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA SynthesisCo-tethered transcription boosts mRNA yield and purity by organizing transcription machinery, reducing dsRNA impurities, and streamlining production for scalable RNA therapeutics.
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![Drone Point View of Overpass and City Traffic at Night-GettyImages-1279832748]( "A New Approach To RNA Synthesis And Purification: Rethinking A Persistent Bottleneck")
A New Approach To RNA Synthesis And Purification: Rethinking A Persistent BottleneckPhotocleavable supports enable light-triggered RNA release, reducing reliance on chromatography and streamlining synthesis, scalability, and purity for complex RNA therapeutics.
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![Genetic Engineering, biotechnology gene analysis-GettyImages-1485674887]( "Oligos, mRNA, Or Gene Editing: Where Should You Bet?")
Oligos, mRNA, Or Gene Editing: Where Should You Bet?Investing in RNA and gene editing requires balancing risk, timing, and scale — understanding how oligos, mRNA, and CRISPR each drive value across a converging biotech landscape.
MANUFACTURING VIDEOS
Is enzymatic ligation a futuristic dream or a current commercial reality? In this segment, industry experts Claire McCleod and Jill Caswell explore how the sector has moved past the proof-of-concept stage into early commercialization and what this looks like/means for early adopters today.
As Pfizer and Moderna publicly announce work on an mRNA-based universal flu vaccine, what else is on the horizon for mRNA? Tune in to this segment from the Bioprocess Online Live event mRNA Manufacturing: Bright Future, Big Challenges for a discussion with Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx. In this clip, they share market forecasts for mRNA vaccines and therapeutics and their companies’ go-forward plans to meet those demands.
Watch to learn when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for various drug products.
By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.
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![GettyImages-1327112218 Scientist using a laptop in a laboratory]( "Tackling Antimicrobial Resistance")
Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.
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See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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![QA-Quality Assurance-GettyImages-1184320070]( "5 Areas To Focus Your QRM Strategy For Sterile Drug Products")
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "The Crucial Role Of Downstream Processing In Optimizing RNA-LNP Drug Development")
Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.
