MANUFACTURING ARTICLES
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Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics
RNA 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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A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products
NIST 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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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.
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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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The Delivery Challenge For In Vivo Cell Engineering
As 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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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.
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Scaling cell and gene therapy operations in EMEA demands strategic planning, regulatory alignment, and robust logistics to meet growing demand and ensure consistent delivery across diverse markets.
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Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.
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Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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Learn how optimizing LNPs can help overcome drug-delivery challenges, unlocking potential new genomic medicines in a shorter time.
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Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.