Mesoblast's Silviu Itescu shares how two decades of rigorous science and manufacturing turned allogeneic MSCs into the first FDA-approved cell therapy while building a scalable platform for inflammatory diseases such as GvHD, back pain, and heart failure.
- January 2026 — CDMO Opportunities And Threats Report
- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- Why Clinical Supply Risk Starts With Demand Signals
- A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- In Vivo's Biggest Threat — Comparison To Old Models
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![SpectraMax iD5e multi-mode microplate reader plate tray open microplate showcased improve cell viability]( "Improved Cell Viability For Multi-Day Cell-Based Assays")
Improved Cell Viability For Multi-Day Cell-Based AssaysEnsure consistent cell health and assay reliability with controlled temperature and gas conditions. Discover how microplate readers with gas mixers enhance cell viability in live cell-based assays.
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![GettyImages-931182764 Cheerful Office Workers On Laptops]( "Reframing Clinical Vendor Selection")
Reframing Clinical Vendor SelectionExplore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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![Removing frozen single use bags]( "Optimize The Freezing Process With A Liquid Nitrogen Freezer")
Optimize The Freezing Process With A Liquid Nitrogen FreezerTake a closer look into research aimed at enhancing the cryogenic freezing process of the mammalian CHO-K1 cell line using a controlled-rate liquid nitrogen freezer.
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![Computer Science Research Laboratory with Robotic Arm Model-GettyImages-968289652]( "ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials")
ICH E6(R3) In Effect: Transforming Quality Management For CGT TrialsDiscover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.
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![Pharma Manufacturing GettyImages-1135140594]( "The State Of Digital Maturity In Pharma And Medtech Manufacturing")
The State Of Digital Maturity In Pharma And Medtech ManufacturingExplore results from a study aiming to understand why numerous companies continue to rely on manual, paper-based systems, and gain insight into how your competitors are gaining a competitive advantage.
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![chrom system app note pic]( "Scalability And Reproducibility Of The AAV9 Capture Step")
Scalability And Reproducibility Of The AAV9 Capture StepScaling gene therapies beyond rare diseases demands innovation. Discover a chromatography system that boosts efficiency, protects product integrity, and overcomes viral vector manufacturing challenges.
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![GettyImages-1285212896 lab]( "Large Scale Purification Of Oligonucleotides With IEX")
Large Scale Purification Of Oligonucleotides With IEXAs oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.
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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-1158419849 lab]( "Formulation Development For Therapeutic Oligonucleotides")
Formulation Development For Therapeutic OligonucleotidesDiscover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.
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![GettyImages-1388184871-quality-compliance-approval]( "Immuno-Oncology Biomarker Measurement With High Sensitivity And Speed")
Immuno-Oncology Biomarker Measurement With High Sensitivity And SpeedExplore results demonstrating the successful use of innovative ELISA assays to detect three key biomarkers: Programmed Death Ligand 1 (PD-L1), Interleukin-8 (IL-8), and Interferon Gamma (IFN-γ).
NEWSLETTER ARCHIVE
- 02.19.26 -- Advancing Your Cell and Gene Therapy Journey
- 02.19.26 -- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- 02.18.26 -- Specialized Fill/Finish For Advanced Therapies
- 02.18.26 -- Cold-Chain Packaging Strategies For Scaling Gene Therapies
- 02.18.26 -- Building Safer CRISPR Medicines For CVD With Benjamin Oakes
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
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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