MANUFACTURING ARTICLES
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![genetic engineering and gene manipulation, CRISPR technology, genome editing, molecular biotechnology, genetic science research, gene therapy-GettyImages-2196575232]( "From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics")
From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR TherapeuticsGuide RNA is evolving from a simple targeting reagent into a complex, engineered molecule shaped by expanding CRISPR modalities, increasing length and modification demands, and tighter integration with manufacturability, analytical control, and regulatory expectations.
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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.
MANUFACTURING VIDEOS
Learn about the development and advantages of a new affinity ligand platform. It provides versatile, single-step purification for recombinant proteins and virus particles, enhancing yield and purity.
Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.
Watch to learn when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for various drug products.
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![171026-101024_MDA_F61_12673_FINAL]( "Integrated Approach In Managing CPV And APQR")
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
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![mRNA GettyImages-1428646288]( "Suitability Testing For IVT mRNA Analysis")
Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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![mRNA iStock-1295693748]( "Efficient, Scalable Purification Of mRNA By Affinity Chromatography")
Increasing demand for mRNA as a therapeutic product requires efficient, scalable purification methods. Here, a monolithic stationary phase is used to purify mRNA from a capping mix of Luc2 RNA.
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![iStock-1140779660-drug-development-lab]( "Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies")
Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.
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![iStock-1290118109-mrna-vaccine-covid-corona]( "Key Insights Into Overcoming mRNA Process Challenges")
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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![risk]( "Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective")
This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.
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![Scientists in lab-GettyImages-1441665026]( "Strategize For Success With Single-Use Biomanufacturing Systems")
Single-use technologies are reshaping biomanufacturing workflows. Discover the key stages of implementation and how strategic choices drive success across the entire production process.
