MANUFACTURING ARTICLES
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![GettyImages-532447321-children-kids-workout-exercise]( "From \"Up & Coming\" To \"Fully Formed\": Maturing Our mRNA Outsourcing Partnerships")
From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing PartnershipsIn the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.
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![Chilli pepper on fire-GettyImages-164646124]( "A \"Hot Take\" On mRNA Critical Process Parameters")
A "Hot Take" On mRNA Critical Process ParametersBushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production.
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![Taking a shortcut-GettyImages-2101007925]( "End-To-End mRNA DS And DP Manufacturing Processes")
End-To-End mRNA DS And DP Manufacturing ProcessesThis article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.
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![scientist experimented in laboratory-GettyImages-909089478]( "Making Cancer Vaccines Is Complex; New Platform Guidance Could Help")
Making Cancer Vaccines Is Complex; New Platform Guidance Could HelpFDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.
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![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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![Hydraulic lift platform-GettyImages-821833040]( "What Does FDA's Draft Platform Guidance Mean For CGT Companies?")
What Does FDA's Draft Platform Guidance Mean For CGT Companies?Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
MANUFACTURING VIDEOS
The NanoAssemblr® Spark™ uses proprietary microfluidics technology for the controlled and reproducible manufacturing of nanoparticles in small volumes in less than 10 seconds.
Explore the broad benefits and challenges that could be encounter by working with self-amplifying and circular RNA modalities — particularly in terms of manufacturing, raw material supply, COGS, and patient centricity.
Learn about the key aspects of aseptic sampling, appropriate methods and circumstances to perform sampling, and impact a platform and sample containers can have on assay results and process dynamics.
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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![Covid Vaccine Production Line GettyImages-1336518535]( "Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development")
One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.
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![GettyImages-517743436-plasmid-dna-development-lab]( "mRNA Manufacturing Workflow: Get To Clinic And Market Faster")
Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
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The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.
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![Molecule mRNA-GettyImages-1428646288]( "Optimized Performance Model For Yield And Quality Of The mRNA Product")
Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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![Virus and Genes iStock-843037718]( "Downstream Process For Gene Therapy, Plasmid-DNA Vaccine Development")
A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.
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![GettyImages-1087219020 Scientists wearing protective coveralls working in manufacturing laboratory]( "Insights Into GMP Manufacturing Of RNA-LNP Drug Products")
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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![Hand putting print screen dart and target board wooden cube on up arrows Getty Images-1223992751]( "Process Development Services")
Before scaling up or out, developing and optimizing your process is crucial to reduce the risk of scaling your inefficiencies. Discover process development services designed to help meet your PD goals.
