MANUFACTURING ARTICLES
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
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![Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415365]( "Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide Therapeutics")
Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide TherapeuticsChemoenzymatic ligation could overcome the scalability and sustainability limits of traditional oligonucleotide manufacturing, enabling more efficient RNA drug production.
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![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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![Small interfering RNA, sirna, mrna, crispr-GettyImages-1409578453]( "Building A Self-Driving Lab For LNP Development")
Building A Self-Driving Lab For LNP DevelopmentWith commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
MANUFACTURING VIDEOS
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 2, Welch outlines how The Game of RISK can serve as a great example for the mRNA therapeutics industry in its long-term quest to standardize the mRNA drug product manufacturing paradigm.
In this clip, Advancing RNA Live panelist Venkat Krishnamurthy unpacks how solid-phase synthesis has been improving to overcome current challenges with gRNA production, while Max De Long and April Sena share their perspectives on the maturity of current CDMO platforms for enzymatic ligation of gRNA.
Multiple steps in the mRNA manufacturing process can appear more complex than they have to be. Learn how to simplify your approach and produce the best possible mRNA vaccines and therapeutics.
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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![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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![Scientist lab discussion meeting GettyImages-1140779742]( "Single Nucleus Dispensing")
Learn how a single cell dispenser was used to isolate single DNA-labeled nuclei to demonstrate compatibility with snRNA-seq workflows.
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![GettyImages-1465316262-computer-magnifying-glass-audit-documents]( "How Global Shifts Are Reshaping ATMP Logistics Beyond Borders")
Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding resilient strategies to ensure uninterrupted delivery of advanced therapies worldwide.
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![The-Column-2]( "A Proven Platform For Solid-Phase Oligonucleotide Synthesis")
Facilitating oligonucleotide synthesis with state-of-the-art equipment and process support is critical to maximizing oligo production and achieving consistency at scale.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Standardization Where It Matters Most")
Freezing doesn’t ensure consistency. Standardized cryopreservation removes site‑to‑site variability, providing predictable starting materials and lowering scientific and operational risk.
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![GettyImages-1327624070-lab-research-development]( "mRNA Manufacturing: Overcoming CMC Development Challenges")
A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.
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![GettyImages-1297146235-dna]( "A Scalable Single-Use Two-Step pDNA Purification Process")
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
