MANUFACTURING ARTICLES
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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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.
MANUFACTURING VIDEOS
Is enzymatic ligation a futuristic dream or a current commercial reality? In this segment, industry experts Claire MacCleod and Jill Caswell explore how the sector has moved past the proof-of-concept stage into early commercialization and what this looks like/means for early adopters today.
Learn about method development considerations when selecting an appropriate ion-pairing agent and impurity analysis of dye-conjugated oligonucleotides.
Though the mRNA industry is excited about the possibilities of the FDA’s yet-to-be-clarified “Platform Provision,” a recent discussion between regulators suggests differences in opinion are emerging.
In this segment of a recent Bioprocess Online Live! panel discussion, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus address a rapid cadence of audience questions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Pushing The Boundaries Of Chromatographic Separation")
Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.
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![PNI Feature 2]( "Strategies To Overcome Delays In The Development Of Genomic Medicines")
Learn how optimizing LNPs can help overcome drug-delivery challenges, unlocking potential new genomic medicines in a shorter time.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
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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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![GettyImages-1214921728-lab-glassware-beaker-vial-test-tube]( "Supporting The Clinical Journey From Discovery To Delivery")
Clinical Trials Day celebrates the science and collaboration driving medical breakthroughs — discover how Cryoport Systems helps power this progress behind the scenes.
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![Thermo Fisher - Peptones]( "The Value Of Peptones For Enhancing Biopharmaceutical Productivity")
Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
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![GettyImages-163113211-south-africa-globe]( "Building Local Biomanufacturing Capacity In South Africa")
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
