FORMULATION ARTICLES
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![neuroscience, neuromuscular disorders, pain signals, rehabilitation-GettyImages-2280116713]( "Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics")
Why Delivery Is Defining The Next Era Of Neuromuscular TherapeuticsEmerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
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![GettyImages-1316503044-dna-strand-double-helix-gene-editing]( "The Second Holy Grail Of Gene Editing: Large Knock-Ins")
The Second Holy Grail Of Gene Editing: Large Knock-InsExploring the race to achieve large gene knock-ins, emerging editing platforms, and how overcoming this challenge could unlock therapies for many inherited diseases.
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![GettyImages-1358847958]( "From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA Expansion")
From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA ExpansionObviously, the transition from RNA vaccines to therapeutics is an “expansion” all on its own; but to do this successfully, we need to expand our science, our products’ deliverability, and our patient access. In the following article, I highlight a few of the best practices and/or innovations that came up in conversation during this event that will play a significant role in helping us expand mRNA’s reach, both scientifically and therapeutically.
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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
FORMULATION VIDEOS
Explore how lipid nanoparticles are revolutionizing non-viral gene editing with scalable, efficient delivery for both ex vivo and in vivo applications, which features new CRISPR-LNP data in T cells.
Explore the science behind LNP formulation development, from ionizable lipids to scalable manufacturing through case studies, screening strategies, and flexible approaches for advancing next-generation therapeutics.
Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.
Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Regulatory Considerations For Excipients Used In Lipid Nanoparticles")
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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![scientist laboratory microscope-GettyImages-1253518521]( "Cell And Virus Banking In OV Development And Manufacturing")
Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
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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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![Cryopreservation GettyImages-172640159]( "The Slow Drift Toward Variability And The Case For Standardization")
Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.
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![Lipid Nanoparticles GettyImages-1437855772]( "How Lipid Nanoparticles Enable Next-Gen Delivery")
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
