FORMULATION ARTICLES
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
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2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA Therapeutics
As RNA therapeutics mature, 2026 will reward execution over novelty. Delivery, data-driven design, and modality specialization will determine which RNA platforms scale clinically and commercially.
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Designing mRNA For The Next Generation Of Therapeutics
mRNA’s next leap goes beyond vaccines. This piece explores how tuning sequence design, structure, and longevity enables controlled protein expression for cancer, rare disease, and regenerative uses.
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The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.
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Lipid nanoparticles (LNPs) function as a drug delivery system for nucleic acids. Learn about the biomedical applications of LNPs as well as the anatomy, formulation optimization, and safety of LNPs.
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The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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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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Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.
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Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry.