FORMULATION ARTICLES
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![Insomnia-GettyImages-1435316951]( "Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At Night")
Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At NightIt goes without saying that there’s a lot we need to understand about how our drug products’ composition (i.e., lipid/mRNA ratio) analytical profile, and manufacturing process impact their potency and safety. But I also appreciated the panels’ focus on the importance of gaining a clearer understanding of the biological factors that influence the strength, durability, immunogenicity, and overall deliverability of our RNA therapeutics in vivo.
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![GettyImages-1459130563]( "Collaboration Key To Going \"Out On A Limb\" For Nonviral mRNA Delivery")
Collaboration Key To Going "Out On A Limb" For Nonviral mRNA DeliveryAs the members of this panel at the World Vaccine Congress emphasized, they see great — and in some cases untapped — opportunities for collaboration to better advance nonviral delivery of a wide variety of RNA therapeutics.
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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.
FORMULATION VIDEOS
Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, address audience questions around the importance of drug substance and drug product stability in efficient delivery in this segment of the Bioprocess Online Live! event LNPs & Beyond: Opportunities in RNA Delivery.
This webinar is presented by Dr. John P. Cooke, Chair of the Department of Cardiovascular Sciences at the Houston Methodist Research Institute, Director of the Center for Cardiovascular Regeneration, and Medical Director of the RNA Therapeutics Program in the Houston Methodist DeBakey Heart and Vascular Center.
Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-96310150-microfluidics.jpg]( "Getting Genomic Medicines Ready For Prime Time")
Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, and more.
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![mRNA iStock-1295693748]( "Transfection Solutions For Highly Reliable And Effective Gene Silencing With siRNA And Co.")
We discuss the process of transfection and highlight two highly effective vectors for both in vitro and in vivo gene therapy applications.
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![mRNA GettyImages-1356994684]( "Freezing mRNA: Best Practice")
By following some of the best practices in freezing mRNA, you can effectively balance product quality, cost-effectiveness, process safety, and efficiency.
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![GettyImages-1194781834-cell]( "mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations")
Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.
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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.
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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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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
