Engineered oncolytic viruses are emerging as a promising way to target tumors, deliver immune-stimulating payloads, and improve treatment of metastatic cancer.
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
- A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
- Inside AstraZeneca's Fully Electrified Cell Therapy Facility
- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CDMO Selection: Start With The Relationship, Not The RFP
- Why FAT Should Confirm Alignment, Not Reveal Its Absence
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Innovating The mAb Characterization Process
Understanding the characteristics of a molecule's "personality" is crucial for optimizing development and manufacturing. Learn how to overcome the challenges in the characterization process.
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A Journey To Produce MSC-Derived Cell Therapies From Isolation To Large-Scale
Drive successful MSC therapy development by optimizing isolation methods, surface chemistry, and closed-system expansion technologies to ensure cellular stability and commercial scalability.
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Cell-Free Modeling Approach For Efficient Cell Culture Monitoring
Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.
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Pre-Launch Checklist - A Roadmap To Success
The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.
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Partnering With Health Systems: Essential Tips For CGT Commercialization
Successful 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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Large-Scale Exosome Production Stirred-Tank Bioreactors
Discover how engineered exosomes, displaying tumor-homing peptides, offer a promising tool for targeted cytotoxic drug delivery, produced efficiently with a bioreactor for critical research.
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How A QMS Embeds Quality Into Cell Therapy Production
Discover how a digital manufacturing solution helped a cellular therapy leader eliminate cleanroom paper, align quality teams, and accelerate batch release times by nearly 50%.
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Anticoagulant Selection Influences T Cell Purity And Yield In Whole Blood Isolation
Lithium heparin reduces T cell purity to below 50% and spikes CD15+ contamination in whole blood workflows. See which anticoagulants consistently deliver above 90% CD3+ purity.
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The Open Standard For Plug-And-Produce
Take a look at how standardized, modular production simplifies line integration, reduces engineering effort, and enables faster changeovers. Ideal for teams seeking flexible manufacturing models.
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Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
NEWSLETTER ARCHIVE
- 06.12.26 -- Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge
- 06.11.26 -- Translating Discovery Into Clinical Success
- 06.11.26 -- Bridging Innovation And Manufacturing In Cell & Gene Therapy
- 06.11.26 -- Why Contamination Control By Design Should Matter To Your CDMO
- 06.10.26 -- Control Contamination In Material Transfer Process
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
- Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D
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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