MANUFACTURING ARTICLES
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![DNA Helix, Futuristic Digital Interface, genetics, molecular biology, gene editing-GettyImages-2221747428]( "A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA Synthesis")
A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA SynthesisCo-tethered transcription boosts mRNA yield and purity by organizing transcription machinery, reducing dsRNA impurities, and streamlining production for scalable RNA therapeutics.
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![Drone Point View of Overpass and City Traffic at Night-GettyImages-1279832748]( "A New Approach To RNA Synthesis And Purification: Rethinking A Persistent Bottleneck")
A New Approach To RNA Synthesis And Purification: Rethinking A Persistent BottleneckPhotocleavable supports enable light-triggered RNA release, reducing reliance on chromatography and streamlining synthesis, scalability, and purity for complex RNA therapeutics.
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![Genetic Engineering, biotechnology gene analysis-GettyImages-1485674887]( "Oligos, mRNA, Or Gene Editing: Where Should You Bet?")
Oligos, mRNA, Or Gene Editing: Where Should You Bet?Investing in RNA and gene editing requires balancing risk, timing, and scale — understanding how oligos, mRNA, and CRISPR each drive value across a converging biotech landscape.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis")
Beyond The Gold Standard(s): Modernizing Oligonucleotide SynthesisA few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
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![Business support, teamwork-GettyImages-2267605245]( "The RNA Ties That Bind: 3 Takeaways From The OPT Congress")
The RNA Ties That Bind: 3 Takeaways From The OPT CongressHere, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.
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![Test Tubes-GettyImages-139700261]( "Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign")
Rethinking ATMP Assurance When Sterility Timelines, Reality MisalignThe compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
MANUFACTURING VIDEOS
Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies.
Efficient mRNA production relies on optimized IVT conditions, where NTPs, enzymes, and critical additives work together. Explore how the right components strengthen mRNA synthesis at every step.
Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus offer insight into CMC considerations and entertain audience questions on the topic.
Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Sartorius CIM HIP Plasmid Process PackTM, CIMac pDNA]( "In-Process Control Of pDNA Production On CIMac™ pDNA Analytical Column")
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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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
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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![Cell Culture Media Filtration]( "Cell Culture Media Filtration: Evaluating Cell Culture Performance")
Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.
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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-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
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![GettyImages-517743436-plasmid-dna-development-lab]( "mRNA Manufacturing Workflow: Get To Clinic And Market Faster")
Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
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![GettyImages-1224202684-laboratory-dna-scientist-research-monitoring]( "Sample Quality Control In Next-Generation Sequencing Workflows")
See how automated electrophoresis and key integrity metrics strengthen NGS workflows by improving sample assessment, streamlining QC steps, and supporting confident decisions.
