FORMULATION ARTICLES
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![Genetic engineering, dna-GettyImages-1310083278]( "Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes Next")
Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes NextOligonucleotide therapies have proven clinical value, but scaling beyond rare disease remains hard. William Soliman, Ph.D., BCMAS, breaks down the manufacturing, delivery, and CMC realities shaping what comes next.
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![RNA strands, SiRNA, mRNA, CRISPR delivery-GettyImages-2151198841]( "In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors")
In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid TumorsBy injecting lipid-based nanoparticles encapsulating mRNA and encoding the CAR directly into the bloodstream, developers can effectively reprogram the patient's own immune cells in situ.
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![cancer cell screening, disease treatment medical-GettyImages-2189938556]( "Powering Cell Therapies With RNA: A New Code For Engineered Immunity")
Powering Cell Therapies With RNA: A New Code For Engineered ImmunityRNA is redefining cell therapy engineering—enabling transient, programmable control of immune and stem cells while simplifying manufacturing, improving safety, and accelerating scalable, virus-free workflows.
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![digital exchange, money transfer-GettyImages-2148127398]( "Why RNA Tech Transfer Is So Hard — And How the Field Can Fix It")
Why RNA Tech Transfer Is So Hard — And How the Field Can Fix ItA closer look at why RNA tech transfer remains one of the field’s toughest bottlenecks — and the practical steps developers and CDMOs can take to finally streamline the path to GMP.
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![GettyImages-1128195910-vial-white-powder-lyophilization]( "Four Reasons You Should Choose Lyophilization for Your Next Project")
Four Reasons You Should Choose Lyophilization for Your Next ProjectLyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
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![Gene editing, gene therapy-GettyImages-930103248]( "Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge Ahead")
Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge AheadPersonalized cancer vaccines are becoming feasible, but scaling fast, affordable, data-driven manufacturing is the central challenge to bringing these individualized therapies to more patients.
FORMULATION VIDEOS
Dr. Michael Buschmann, George Mason University, presents an overview of molecular and colloidal ionization properties of lipid nanoparticle mRNA vaccines.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, unpack which learnings can be adapted from ASO-LNPs to mRNA/LNPs and from mRNA vaccines to mRNA therapeutics. They also touch upon which learnings cannot be neatly carried over from these previous success stories.
Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.
Dr. John Lewis, Founder and CEO, Entos Pharmaceuticals, presents RNA Vaccine Development to Phase I.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Trends In Next-Generation Delivery Technologies")
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
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![GettyImages-1317697233-cancer-t-cells]( "A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy")
We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility")
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy")
Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
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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-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs")
This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.
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![GettyImages-597935610 cell and gene]( "Delivering The Promise Of Gene Therapy")
Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.
