Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls.
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- Wondering If Your Org Should Purchase R&D Datasets?
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1500981700 cell culture]( "Automated DNA Clean-Up Using Magnetic Bead-Based Methods")
Automated DNA Clean-Up Using Magnetic Bead-Based MethodsDiscover how to improve DNA clean‑up through a precise magnetic bead–based workflow, as well as how optimized liquid handling enhances yield, purity, and reproducibility for higher confidence in results.
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![GettyImages-185298052-ddPCR]( "ddPCR Workflows For Gene Expression Analysis")
ddPCR Workflows For Gene Expression AnalysisRT-ddPCR offers a powerful, flexible approach to precise RNA quantification. Learn how one-step and two-step workflows improve sensitivity and efficiency in your gene expression studies.
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "Optimization And Scale-Up Of A Plasmid DNA Production Process")
Optimization And Scale-Up Of A Plasmid DNA Production ProcessOptimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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![Researcher laboratory virus GettyImages-1212345443]( "Ensuring Viral Safety Through Multiplexed Adventitious Virus Detection")
Ensuring Viral Safety Through Multiplexed Adventitious Virus DetectionGain a targeted look at multiplex digital PCR that detects diverse human viral contaminants with speed, sensitivity, and precision. Learn how high‑multiplex workflows support QC needs.
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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
Improve Speed To Market By Mitigating Vial And Stopper IncompatibilityThese studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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![Scientists In Lab Working Together On Digital Tablet GettyImages-893884830]( "The Complete Guide To Immunohistochemistry")
The Complete Guide To ImmunohistochemistryImmunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
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![GettyImages-1220382102-lab-research]( "A Scalable Platform To Revolutionize Gene Therapy Manufacturing")
A Scalable Platform To Revolutionize Gene Therapy ManufacturingDiscover how our innovative rAAV production platform can revolutionize your gene therapy pipeline with unparalleled yield, quality, and scalability.
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![GettyImages-1347856166 tube, research, lab]( "Overcoming Scale-Up Challenges In iPSC Production: A Joint Investigation")
Overcoming Scale-Up Challenges In iPSC Production: A Joint InvestigationDiscover how new processing methods tackle challenges in large-scale stem cell production and how automated, low-shear processing maintains cell health and pluripotency across production scales.
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![iStock-1287080337-lab-microscope-scientist-research.jpg]( "Unraveling The Complexity Of Cell Therapy: Advancements And Challenges")
Unraveling The Complexity Of Cell Therapy: Advancements And ChallengesCell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.
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![GettyImages-1288978528 Scientist Using Microscope In Lab]( "Simpler, Faster, Cheaper Advanced Therapy Manufacturing")
Simpler, Faster, Cheaper Advanced Therapy ManufacturingDiscover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.
NEWSLETTER ARCHIVE
- 07.11.26 -- Cell & Gene Newsletter - Best Of June
- 07.10.26 -- Managing Supply Disruptions In ATIMP Clinical Trials
- 07.09.26 -- From Clone To Commercial: Redefining Cell Therapy Workflows
- 07.09.26 -- Applying Contamination Control By Design: A Practical Guide For CDMOs
- 07.08.26 -- Why In Vivo Therapies Are Moving Toward the Clinic with Ascidian Therapeutics' Dr. Mike Ehlers
- 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
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
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.
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