MANUFACTURING ARTICLES
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
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![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
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![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA 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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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST 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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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
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.
MANUFACTURING VIDEOS
Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most important regulatory considerations for gRNA production utilizing an enzymatic ligation approach.
In this snippet, panelist Alex Aust (with the help of several live attendee commenters) tackles a particularly tricky question: Are our outsourcing partnerships producing high quality products today, and what are the most common root causes of batch failures?
Explore best practices for developing a QC method for identification and impurity analysis of oligonucleotides, as well as tips on mitigating risk by using compliant instrumentation and software.
As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Sustainable green building-GettyImages-1468396766]( "How Is Additive Manufacturing Delivering On Sustainability Goals?")
One of the key concerns for many biopharmaceutical companies is minimizing environmental impact. Learn about additive manufacturing and the significant advantages it offers to biomanufacturers.
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![mRNA GettyImages-1356994684]( "mRNA Manufacturing And Formulation")
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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![Gene Therapy GettyImages-1164556175]( "mRNA Product IVT Process Insights")
In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
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![QA-Quality Assurance-GettyImages-1184320070]( "5 Areas To Focus Your QRM Strategy For Sterile Drug Products")
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.
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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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![GettyImages-2232165715-oligonucleotide-render-3d]( "Comprehensive Characterization Of Oligonucleotides And Related Impurities")
A two-dimensional LC/MS strategy improves the separation of coeluting oligonucleotide impurities. High-resolution sampling and automation enable deeper characterization of low-level variants.
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![BioSpring Waters Inc]( "Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio")
CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
