MANUFACTURING ARTICLES
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![small business search-GettyImages-149282415]( "FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers")
FDA's Platform Guidance Raises Long-Term Questions For mRNA MakersAs I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.
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![Hot chilli peppers-GettyImages-154890138]( "Two \"Spicy\" Takeaways On The FDA's Platform Designation Guidance")
Two "Spicy" Takeaways On The FDA's Platform Designation GuidanceOver the past few weeks since the guidance was released, I’ve spent some time listening to industry conversations and reading the guidance and related articles. In the following series of articles, I’ll share a few general impressions and (slightly spicy) thoughts I’ve been mulling over in response to the draft guidance.
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![tubes purify dna-GettyImages-2163770679]( "Developing & Manufacturing Oligonucleotides: An Overview")
Developing & Manufacturing Oligonucleotides: An OverviewAn overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.
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![Trendy Question-GettyImages-1048454724]( "Is This The Hardest Question Facing mRNA Therapeutics Makers?")
Is This The Hardest Question Facing mRNA Therapeutics Makers?As I’ve been reminded on a few different occasions, there is a difficult truth we may need to wrap our brains around in certain situations: Just because we can make an mRNA therapy for an indication, doesn’t necessary mean we should — or that the patient population will necessarily want it or be able to access it.
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![Cleaning detergents vaccine lab science-GettyImages-1365807469]( "Scaling RNA Production From The Lab To The Clinic")
Scaling RNA Production From The Lab To The ClinicNutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.
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![Microbiology laboratory work-GettyImages-1483940532]( "Rising Allure And Critical Considerations Of Point-Of-Care Processing")
Rising Allure And Critical Considerations Of Point-Of-Care ProcessingMobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.
MANUFACTURING VIDEOS
Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.
In this clip from a recent Advancing RNA LIVE event, panelists address a question about where the best opportunities exist upstream and/or downstream to increase mRNA manufacturing efficiencies.
Learn about a complete purification process flow that overcomes the challenges of producing pDNA – a critical first step in mRNA manufacturing – and covers all downstream unit operations.
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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![Cell Gene Technology]( "Where Can Novel Non-Viral Polymeric Delivery Agents Take Us?")
Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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![Lab cell and gene pipette GettyImages-162264253]( "mRNA/saRNA Manufacturing RNA Production & Manufacturing")
Venkata Indurthi, Ph.D., discusses key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.
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![Thermo- HoodLab3Scientists]( "Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality")
Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.
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![MicroSEQ Rapid Microbial Identification System]( "Compatible Platforms For Microbial Identification")
Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.
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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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![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.
