FORMULATION ARTICLES
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![shocked surprised-GettyImages-1361394182]( "Two \"Hot Takes\" On mRNA Delivery")
Two "Hot Takes" On mRNA DeliveryAs I argued in a previous “Hot Take,” “the devil is in the details” when it comes to developing both our drug substances and our drug products. We need to get to the point where we have more details and knowledge about alternative methods of delivery (beyond LNPs) so we can make educated decisions on the best path forward for delivering our products.
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![Advertizing-announcement-GettyImages-1784616580]( "A \"Hot Take\" On mRNA Scale-Up")
A "Hot Take" On mRNA Scale-UpIn the following multi-part “mini-series” of RNA industry “Hot Takes,” I share several aspects that jumped out at me from the BioPhorum ATMP Event — starting with several takeaways about mRNA scale-up.
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![Lipid Nanoparticles GettyImages-1437855772]( "Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing")
Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle ManufacturingLipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.
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![Recording-GettyImages-851832858]( "Forum Notebook: Quick Takes From USP's mRNA Virtual Summit")
Forum Notebook: Quick Takes From USP's mRNA Virtual SummitThe United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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![GettyImages-1336155177]( "“Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] Space")
“Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] SpaceIn the first- of this two-part article, Koeris and I ford through some of the most prominent delivery-vehicle development pain-points that don’t get nearly as much conversation as they should today. Though Koeris did not sugarcoat his concerns with some of our current mRNA delivery/LNP development limitations, the questions he posed and considerations he offered give us clearer direction around where we must pursue more scientific “heroism” in the mRNA space.
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![GettyImages-1418152314]( "Unpacking The Importance Of Lipid Nanoparticle Production Platforms")
Unpacking The Importance Of Lipid Nanoparticle Production PlatformsBatch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
FORMULATION VIDEOS
How can PCR-based technology accelerate mRNA development and manufacturing and design principles/critical parameters to enable the rapid development of lipids for RNA formulation?
In this segment, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss which ongoing industry efforts to improve LNPs and the RNA/mRNA cargo they're watching closely that could help the RNA industry move beyond hepatic delivery.
Dr. Jason Coleman, Clinical Application Scientist Lead with Precision NanoSystems, presents on an overview of the development and scale-up activities needed to progress this saRNA vaccine to the clinic.
Dr. Michael Buschmann, George Mason University, presents an overview of molecular and colloidal ionization properties of lipid nanoparticle mRNA vaccines.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Lowering The Lipid Barrier To RNA-LNP Therapeutics")
Industry experts discuss current and future trends, formulating successful lipid compositions and navigating the constantly evolving genomic medicine landscape.
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![iStock-1213713667-viral-vector-virus]( "Gene Therapy And Oligonucleotide Compendium")
Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.
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![iStock-1213444268-vaccine-virus-syringe]( "PEG In LNP Formulations: Addressing Challenges And Seeking Solutions")
Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.
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![GettyImages-1358868801 antibodies]( "How mRNA Technology Engineers Next-Generation Antibodies")
Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery.
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![Precision NanoSystems Feature]( "Understanding The Microfluidic Platforms For Scaling Nanoparticle Production")
Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
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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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![Medical scientists analyzing research-GettyImages-1413600685]( "Developing A Comprehensive Regulatory Approach For LNP Drugs")
The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
