MANUFACTURING ARTICLES
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RNA Platforms: What Transfers And What Breaks
A practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
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Stay "Stereocurious": What The Future Holds For Oligo Quality
Overall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
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Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)
Part 2 explores the downstream technologies that turn RNA into a therapeutic product, from impurity removal and LNP formulation to GMP infrastructure and scalable manufacturing.
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What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech Financing
RNA investing has shifted from hype to scalability, forcing companies to prove manufacturability, delivery strength, and platform-wide value.
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RNA Manufacturing Foundations: From DNA Templates To In Vitro Transcription (Pt. 1)
Cell-free RNA production is reshaping biomanufacturing through modular IVT workflows, advanced capping strategies, and scalable DNA template design.
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Engineering RNA Payload Distribution In LNPs To Unlock Higher In Vivo Gene Editing Efficiency
New research shows RNA payload distribution inside LNPs — not just encapsulation efficiency — may be key to unlocking stronger in vivo gene editing performance.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.
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Learn more about oligo workflows and solutions for oligonucleotide process development, from scalable oligo synthesis to cleavage and deprotection, purification, and buffer exchange.
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Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.
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GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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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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Pharma 4.0 and RNA therapeutics are transforming drug manufacturing. Discover how digital tools, real-time monitoring, and scalable platforms are enhancing quality and efficiency in this evolving landscape.