MANUFACTURING ARTICLES
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![quality control, approval-GettyImages-2170531311]( "ICH Revises Q1 Guideline, Advancing Stability Testing Standards")
ICH Revises Q1 Guideline, Advancing Stability Testing StandardsIn April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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![mirror, your true self-GettyImages-1264700812]( "\"Mirror, Mirror…\": Reflections On Reducing mRNA Production COGS")
"Mirror, Mirror…": Reflections On Reducing mRNA Production COGSHere, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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![US Tariffs-GettyImages-2197351521]( "Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers")
Navigating Tariffs: Implications And Strategies For Pharmaceuticals ManufacturersThe U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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![Teamwork, cooperation, partnership-GettyImages-2156102274]( "Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture")
Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And ManufactureNo matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![UK flag icon with a DNA sign-GettyImages-478760944]( "MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs")
MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPsThe U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.
MANUFACTURING VIDEOS
Learn about a small oligonucleotide synthesizer with big impact that features a user-friendly interface, compact footprint, and more. This small scale system is user friendly and supports scale up.
It goes without saying that achieving cell-specific delivery is the most often discussed challenge facing the RNA-LNP field near- and long-term. However, as these three LNP experts share in this Advancing RNA Live clip, they have a whole list of additional R&D and CMC priorities we must address/accomplish to improve RNA-LNPs’ efficacy in personalized and gene therapy approaches.
Discover cutting-edge equipment featuring high-pressure dosing technology that enables the efficient production of LNPs for diverse applications.
Watch this rundown of a novel method for quantifying L-Citrulline, L-Arginine, and L-Argininosuccinic acid using Mitra tip extraction coupled with LC-MS/MS for enhanced accuracy and reproducibility.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2149039471 scientist lab microscope]( "Scalability Of A Flexible, High-Producing Triple-Transfection rAAV Platform")
Explore a demonstration of a scalable, high-yield triple-transfection rAAV platform's flexibility and efficiency, enabling gene therapy production with robust performance metrics and streamlined processes.
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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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![lab virtual science biologic bioprocess 450x300]( "5 Biggest Trends Of Oligonucleotide Manufacturing In 2022")
The rapidly growing market for Oligonucleotide manufacturing represents an opportunity for investors and pharma companies that wish to produce novel pharmaceutical products and therapies.
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![Sartorius]( "Increasing Productivity Of pDNA DSP Using Sample Displacement Chromatography")
Here, two distinct polishing processes using monoliths are compared: bind-elute (BE) and the more recently developed sample displacement purification (SDP).
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![Embracing Ongoing Process Verification in Cleaning Validation]( "Toward A Gene Therapy Platform: What's The Best Format Of TFF?")
Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.
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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. Discover how an analyzer system enhances encapsulation efficiency and critical quality attributes in IVT mRNA workflows.
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![Nanoparticles GettyImages-622777274]( "Exploring Progress In Nanomedicine: Unlocking New Possibilities For Treating Rare Genetic Diseases")
Gene therapy offers hope for rare genetic diseases, with advancements in polymer nanoparticles addressing delivery challenges and paving the way for innovative, effective treatments.
