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- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance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-673804426 aseptic biologics clean room lab]( "Solve ATMP Aseptic Filling Challenges With Gloveless Isolators")
Solve ATMP Aseptic Filling Challenges With Gloveless IsolatorsHuman intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
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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-1480473800 roadmap]( "Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success")
Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered SuccessThe commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
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![GettyImages-1457289257 patient]( "Quantitative ROI With DCTs")
Quantitative ROI With DCTsThrough dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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![GettyImages-2156218287-vial-blood-sample-liquid-biopsy]( "Detect Ultra-Rare Variants In cfDNA From Liquid Biopsy Samples")
Detect Ultra-Rare Variants In cfDNA From Liquid Biopsy SamplesLiquid biopsy, powered by next-generation sequencing, is transforming precision oncology to offer real-time, non-invasive insights into tumor genetics, which revolutionizes how we monitor and manage cancer.
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![GettyImages-2010746888-clinical-meeting-tablet-collaboration]( "Targeted Indication Selection Using Adaptive Design")
Targeted Indication Selection Using Adaptive DesignWhat is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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![Medical research, technology, innovation, AI-GettyImages-2226144959]( "An Overview Of 2026 Life Sciences Industry Trends")
An Overview Of 2026 Life Sciences Industry TrendsExplore the paradigm shift reshaping life sciences. Learn how connecting data streams across the product lifecycle drives predictive compliance and operational excellence.
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![GettyImages-136640925-vial-vaccine]( "The Value Of Peptones For Cost-Effective Vaccine Manufacturing")
The Value Of Peptones For Cost-Effective Vaccine ManufacturingPeptones offer a strategic solution to key biomanufacturing challenges by enhancing cell culture performance, improving yields, and reducing production costs.
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![Cydem VT]( "A High-Throughput Platform For Fast And Reliable Clone Screening")
A High-Throughput Platform For Fast And Reliable Clone ScreeningThe Cydem VT platform consists of several technologies allowing for the cultivation and monitoring of CHO cells in cell line development. Find out how to set up your experiment on this device.
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![Pharmaceutical bioreactor-GettyImages-836094936]( "Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine Concentration")
Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine ConcentrationCD34+ cells isolated from cord blood were expanded in a hollow-fiber bioreactor using a novel cytokine cocktail at one-tenth the standard concentration using a MSC-free coating strategy.
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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