In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
- Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- Addressing The Particulate Challenge In Cell Therapy Products
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Pushing The Boundaries Of Chromatographic Separation")
Pushing The Boundaries Of Chromatographic SeparationMetal-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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![GettyImages-2157709064]( "Key Takeaways And Market Insights From The Inaugural ThinkLive Summit")
Key Takeaways And Market Insights From The Inaugural ThinkLive SummitThe inaugural ThinkLive Cell and Gene Therapy Summit explored the industry’s dynamic landscape, highlighting collaboration, communication, and market access challenges.
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![GettyImages-1405590436-lab-perfusion-cleanroom]( "Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up")
Laminar And Turbulent Mixing Techniques For LNP Formulations Scale UpExplore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.
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![Bioreactor for cell culture-GettyImages-517653054]( "Chimeric Antigen Receptor Plasmid Production")
Chimeric Antigen Receptor Plasmid ProductionParallel single-use bioreactor setups enable faster optimization, improved reproducibility, and smoother transition from development to production—supporting more efficient and consistent cell therapy workflows.
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![GettyImages-2169909644-celll-meabolism-human]( "Novel Cardiotoxicity Evaluation Method Using iPS-Derived Cardiomyocytes")
Novel Cardiotoxicity Evaluation Method Using iPS-Derived CardiomyocytesDiscover how real-time monitoring of glucose and lactate in iPS-derived cardiomyocytes reveals subtle drug-induced metabolic shifts that traditional screening methods often fail to detect.
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![Esco downflow booth]( "Raise Your Standards With Downflow Booth Airflow Containment")
Raise Your Standards With Downflow Booth Airflow ContainmentEnsure personnel safety during hazardous material handling by mastering airflow dynamics and containment screens. Learn to achieve low exposure levels through advanced HEPA filtration methods.
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![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "CQA Assessment Of LNP-Encapsulated IVT mRNA")
CQA Assessment Of LNP-Encapsulated IVT mRNALearn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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![GettyImages-1086892494-bacterial-colony-dish-microscopic]( "Fluorescent Bacterial Colony Selection")
Fluorescent Bacterial Colony SelectionFluorescent reporter genes simplify screening bacterial transformants. Discover a system that automates colony picking to enhance efficiency and precision with fluorescence imaging.
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![Lonza Nucleofector]( "Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT")
Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGTThis paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.
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![GettyImages-1067806062-scientist-lab-vaccine-vial]( "Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis")
Quality Assurance In IVT RNA Vaccine Development Using ElectrophoresisDiscover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
NEWSLETTER ARCHIVE
- 07.30.26 -- Innovations To Support Scale And Efficiency In Your Process
- 07.30.26 -- Addressing The Particulate Challenge In Cell Therapy Products
- 07.29.26 -- Key Considerations for Combination Product Development
- 07.29.26 -- Full FDA Approval For TECELRA Is More Than A Regulatory Win For Solid Tumors
- 07.28.26 -- STREAM Edition: Future CGT Manufacturing Trends, AI Reality Checks, And Phase 1 Strategy
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
More Content Collections
