MANUFACTURING ARTICLES
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![BPO-Modulus-IMG_1]( "Repeating Sanofi's Ballroom Design On Two Continents")
Repeating Sanofi's Ballroom Design On Two ContinentsMoveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.
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![DNA abstract-GettyImages-2223439582]( "Suppressor tRNA Therapeutics: A New Frontier In Treating Genetic Disease")
Suppressor tRNA Therapeutics: A New Frontier In Treating Genetic DiseaseSuppressor tRNAs could unlock a scalable new way to treat genetic diseases caused by nonsense mutations, restoring full-length proteins across multiple indications.
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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.
MANUFACTURING VIDEOS
Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities.
In this Bioprocess Online Live panel, we discuss the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.
Novel excipients or active substances? In this segment of Risk Reduction In mRNA Therapeutic Development, we address the debate and discuss LNP-related inflammatory response concerns.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Guidance-Puzzle-Regulatory-iStock-489087670]( "CMC And Regulatory Considerations For CRISPR Therapies")
This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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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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![Cytiva]( "Designing Agile Manufacturing With An Integrated Drug Product Ecosystem")
Companies aiming to accelerate biomanufacturing operations and use resources efficiently need access to technologies that can safely and efficiently complete their workflow from discovery to delivery.
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Key Stages In mRNA-Based Therapeutic Development")
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
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![Sartorius CIM HIP Plasmid Process PackTM, CIMac pDNA]( "In-Process Control Of pDNA Production On CIMac™ pDNA Analytical Column")
As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Development Of LNP Formulations Using The KNAUER NanoScaler")
Lipid nanoparticles (LNPs) offer a robust solution for nucleic acids. The NanoScaler system optimizes this technology, enabling scalable and reproducible LNP formulations for diverse applications.
