CGT is shifting from technical promise to clinical execution as in vivo approaches reach an inflection point where delivery, durability, specificity, and manufacturability will determine whether the field can turn breakthrough science into safe, scalable, repeatable therapies.
- Strategic Synthesis Of ASGCT And ASCO 2026
- 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
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Corning - hyperstack]( "Expansion Of Human Bone Marrow-Derived MSCs")
Expansion Of Human Bone Marrow-Derived MSCsAchieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.
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![GettyImages-1327318287 cells]( "hiPSC Aggregate Expansion In Stirred-Tank Bioreactors")
hiPSC Aggregate Expansion In Stirred-Tank BioreactorsLearn about a bioreactor-based Human Induced Pluripotent Stem Cell (hiPSC) expansion workflow with the potential to improve cell therapy applications.
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![GettyImages-2213157127-drug-formulation-discovery-pipette-liquid-vial]( "Nucleic Acid-LNP Ultrafiltration And Diafiltration")
Nucleic Acid-LNP Ultrafiltration And DiafiltrationDownstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.
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![Antibody drug conjugates ADCs GettyImages-1715913285]( "Extractables In Single-Use Systems Used In ADC Manufacturing")
Extractables In Single-Use Systems Used In ADC ManufacturingTo address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.
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![scientist experimented in laboratory-GettyImages-909089478]( "Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing")
Comprehensive Pathway To Seamless Scale-Up Of mRNA DP ManufacturingAn integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Quality By Design In The Pharmaceutical Industry")
Quality By Design In The Pharmaceutical IndustryReal-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
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![Thermo - bioreactors]( "The Importance Of Quality In Raw Material Selection")
The Importance Of Quality In Raw Material SelectionLearn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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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-1590452153-assay-well-plate-microcscope-image]( "Rapid Walkaway Solution For Assessing Viability In Cancer Organoids")
Rapid Walkaway Solution For Assessing Viability In Cancer OrganoidsAssess anti-cancer compounds' effects on organoid size and morphology with colorectal cancer organoids as well as discover automated imaging and viability assays to streamline drug screening and aid early identification.
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![GettyImages-2149039471 scientist lab microscope]( "Evaluating The Expression Patterns Of Multiple Inhibitory Receptors")
Evaluating The Expression Patterns Of Multiple Inhibitory ReceptorsDiscover how an innovative approach to interpreting T-cell exhaustion and inhibitory receptor expression is paving the way for innovative therapeutic approaches aimed at rejuvenating T-cell function.
NEWSLETTER ARCHIVE
- 06.15.26 -- Discover The Capabilities Driving Next-Generation Biologics
- 06.15.26 -- A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
- 06.13.26 -- Cell & Gene Newsletter - Best Of May
- 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
- 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
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
- Regeneron Advances In Vivo Gene Therapy For Hearing Loss
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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