With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
- Addressing The Particulate Challenge In Cell Therapy Products
- Let's Stop Treating Allogeneic Cell Therapy As One Thing
- Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Building CGT Manufacturing Capacity For The Next Commercial Era
- Managing The Presence Of Visible Particulates In Cell Therapies
- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1213899382-electrophoresis-pipette-cell-loading]( "Quality Control In IVT RNA Workflow")
Quality Control In IVT RNA WorkflowAccurate sizing and purity checks are essential in IVT RNA workflows. Explore how automated electrophoresis improves QC efficiency and ensures RNA integrity for downstream applications.
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![CPC - aseptic processing]( "The Case For Modernizing Small-Volume Aseptic Processing")
The Case For Modernizing Small-Volume Aseptic ProcessingTube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.
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Simplify Process Scale-Up With An Innovative Single-Use Bioreactor
Consistent cell growth and protein yields from 5 L to 5,000 L show how a unified bioreactor design can simplify scale-up, reduce risk, and accelerate upstream process development in bioproduction.
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![GettyImages-2189138619 lab]( "The Effect Of Mixing Homogeneity In Retentate Vessel")
The Effect Of Mixing Homogeneity In Retentate VesselDiscover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.
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![GettyImages-1382353763-hand-bubble-co2-green]( "Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing")
Bio-Based Polymers Towards Net Zero In Single-Use BioprocessingDecarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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![GettyImages-1213680755-scientist-gloves-assay-cell-culture]( "Bispecific T- Cell Engager (BiTE) Screening, Automated Pipeline")
Bispecific T- Cell Engager (BiTE) Screening, Automated PipelineView automated, high‑throughput BiTE screening in mammalian cells, enabling rapid discovery of efficacious variants through precise genomic integration and scalable workflows.
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![Merck Building-shmear]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Biopharma Supply, Reimagined: Regional, Resilient ManufacturingPersistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![GettyImages-1055095236 patient_nurse]( "Inside The Payer Perspective On Cell And Gene Therapy Coverage")
Inside The Payer Perspective On Cell And Gene Therapy CoverageFind out what 19 US payer organizations revealed about CGT coverage decisions, pre-approval engagement timelines, and the clinical evidence they need most to approve high-cost therapies.
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![GettyImages-1185624320-scientist-lab-smiling]( "Can Your Biopharma Team Keep Unplanned Downtime At Bay?")
Can Your Biopharma Team Keep Unplanned Downtime At Bay?Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.
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![Assessing Particle Generation In A Single-Use Mixing System]( "Assessing Particle Generation In A Single-Use Mixing System")
Assessing Particle Generation In A Single-Use Mixing SystemExplore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.
NEWSLETTER ARCHIVE
- 07.20.26 -- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
- 07.17.26 -- Compliance, Costs, And Site Readiness In CAR-T Clinical Trials
- 07.16.26 -- Why Fit-For-Purpose Manufacturing Is Becoming The Defining Strategy In CGT
- 07.15.26 -- Human-Centric Models For Modern Drug Development
- 07.15.26 -- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- 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
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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