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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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-521848481 clinical trial, patient, diversity]( "Partnering With Health Systems: Essential Tips For CGT Commercialization")
Partnering With Health Systems: Essential Tips For CGT CommercializationSuccessful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Separation Of cfDNA With An NGS Kit On Fragment Analyzer Systems")
Separation Of cfDNA With An NGS Kit On Fragment Analyzer SystemsLearn how precise sizing methods reveal nucleosome patterns in cfDNA and help distinguish true signal from extraction‑related artifacts for more reliable genomic analysis.
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![SUS - homogenization]( "Study: Ensuring Homogeneity In Biopharmaceutical Aliquotation")
Study: Ensuring Homogeneity In Biopharmaceutical AliquotationTired of manual manipulation risks in biopharmaceuticals? Discover how automated homogenization ensures consistent cell counts and concentration levels, improving patient safety and process reproducibility.
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![GettyImages-1441662797-laboratory-scientists-equipment]( "Pave The Way To High Productivity With Continuous Manufacturing For Pharma")
Pave The Way To High Productivity With Continuous Manufacturing For PharmaContinuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.
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![GettyImages-2158862132-vials-robotic-arm-filling-liquid-handling-lab]( "Aseptic Process Design And Simulation Under Annex 1 Guidelines")
Aseptic Process Design And Simulation Under Annex 1 GuidelinesGain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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![Proconnex]( "Control pH Adjustment And Reduce Complexity")
Control pH Adjustment And Reduce ComplexityLearn how automated, banded pH control uses dose-and-wait logic to limit overshoot, account for mixing and buffer effects, and maintain stable setpoints across changing fill volumes.
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![GettyImages-1746637448-laboratory-tablet-analysis-vial]( "Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNA")
Liquid Biopsy-Based Detection Of PIK3CA Mutations From cfDNADiscover how ultra-sensitive digital PCR workflows use an innovative system to enable precise detection of rare PIK3CA mutations in cfDNA and advance personalized cancer treatment.
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![GettyImages-1382353763-computer-medical-documents-review]( "Building A High-Quality IND From Scratch With Strategic Gap Analysis")
Building A High-Quality IND From Scratch With Strategic Gap AnalysisA biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
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![Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization]( "Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization")
Stabilization Of RNA-Loaded Lipid Nanoparticles By LyophilizationDiscover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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![GettyImages-2223536069 protein]( "Advances In High-Concentration Protein Formulation Development")
Advances In High-Concentration Protein Formulation DevelopmentHigh-concentration protein formulations improve patient convenience but face challenges like viscosity, aggregation, and surfactant degradation. Innovative strategies optimize stability, scalability, and quality for advanced biologics development.
NEWSLETTER ARCHIVE
- 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
- 07.07.26 -- STREAM Edition: Targeting Tau In Alzheimer's Disease With Voyager Therapeutics' Al Sandrock, M.D., Ph.D.
- 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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