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
Explore the evolution of the mRNA-based therapeutics pipeline, and gain insights into the key quality attributes and associated analytics that influence mRNA performance, including best practices.
Build scalable material sourcing strategies for R&D and early phases through to commercialization and learn how to accelerate the development process and ensure the scalability of your biologics.
Advancing RNA Live panelists identify what is “as good as we can get right now” in terms of understanding our IVT reactions while sharing their ideas on how we can arrive at a future that includes real-time monitoring of our drug substance production processes.
Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-648181930-viral-development-vaccine-lab]( "mRNA/saRNA Manufacturing - RNA Therapeutic Delivery And Applications")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including insight into RNA delivery and the applications–present and future–that innovations in the field are enabling.
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![DNA strand virus-GettyImages-1755616400]( "The Future Of mRNA For Cancer Treatment")
As additional mRNA-based cancer immunotherapies vaccines enter clinical development, operational and supply chain challenges must be addressed to reduce turnaround times and COGS.
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![Bio4C ProcessPad Pattern Search Feature]( "How Pattern Search Finds Anomaly Patterns In Historical Machine Data")
Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools.
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![Evonik1]( "How mRNA Technology Is Shaping The Future Of Medicine")
Discover how mRNA technologies open the doors to a whole range of new gene therapies and the role of lipid nanoparticles (LNPs) in current and future developments.
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![laboratory scientist data iStock-1209661942]( "Ultrafiltration Devices And Plates Offer Higher-Throughput Options For Cloning And PCR Workflows")
Learn how ultrafiltration devices in various steps of the cloning workflow can provide a more streamlined process compared to traditional methods of subcloning PCR-generated fragments.
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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Use Of Filtration Plates For Purification Of DNAs For Sequencing Library Preparation")
Discover how we examined a DNA sample purification method employing 96-well filter plates as an alternate to organic extraction.
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![Gene Therapy GettyImages-1164556175]( "mRNA Product IVT Process Insights")
In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
