FORMULATION ARTICLES
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Why RNA Tech Transfer Is So Hard — And How the Field Can Fix It
A 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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Four Reasons You Should Choose Lyophilization for Your Next Project
Lyophilization 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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Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge Ahead
Personalized cancer vaccines are becoming feasible, but scaling fast, affordable, data-driven manufacturing is the central challenge to bringing these individualized therapies to more patients.
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Strained Manufacturing, Complexity Stymie In Vivo Progress
Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
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To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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RNA's Evolutionary Logic Is Quietly Rewriting The Future Of Therapeutics: A Conversation With Ahmet Berkyurek
RNA’s adaptive logic is reshaping how therapies are designed. Ahmet Berkyurek explains why embracing evolution—not engineering against it—may unlock the next generation of RNA medicines.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Understand how turbulent-jet mixing ensures predictable and reproducible nanoparticle size and uniformity across all scales, accelerating development and regulatory readiness.
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Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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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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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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A platform that harnesses microfluidic mixing has been demonstrated as a simple, robust, and scalable production method for LNPs encapsulating various types of nucleic acids.
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Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.