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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![Targeted Gene Therapies, AI-Powered Genomic Analysis-GettyImages-2196602729]( "Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder")
Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic DisorderGlobal approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
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![West-PO 3 - GCApp]( "Meeting Annex 1: A Proactive Approach To Regulatory Compliance")
Meeting Annex 1: A Proactive Approach To Regulatory ComplianceIt was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
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![GettyImages-1790778296-laboratory-research-sample-prep]( "Streamlining Analytical Release Testing With Faster, Smaller Workflows")
Streamlining Analytical Release Testing With Faster, Smaller WorkflowsReducing turnaround times and sample volumes in release testing can accelerate cell therapy manufacturing, preserve product yield, and improve patient outcomes.
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![Thermo - intuitive bioprocess scale-up]( "Intuitive Bioprocess Scale-Up From Bench Scale To Pilot Scale")
Intuitive Bioprocess Scale-Up From Bench Scale To Pilot ScaleThis study explores scaling a high-demand fed-batch process from bench to pilot scale, highlighting control parameter differences at 50L and 500L while maintaining consistent growth and product titers.
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![Scientist, laboratory, microscope analysis-GettyImages-1530246394]( "Human Platelet Lysate (hPL) Improves Expansion Of MSCs")
Human Platelet Lysate (hPL) Improves Expansion Of MSCsLearn how human platelet lysate significantly improves mesenchymal stromal/stem cell expansion and eliminates the need for plate coating, boosting yield without altering cell phenotype.
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![GettyImages-1590576166 cells, research, lab, assay]( "Rapid Production Of Assay Ready Cells For GPCR Drug Discovery")
Rapid Production Of Assay Ready Cells For GPCR Drug DiscoveryAccelerate drug discovery by leveraging transiently transfected assay-ready cells. This method improves assay sensitivity and reduces variability for GPCRs.
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![GettyImages-1225652892-amino-acid-chain-3d-render]( "Surveying Amino Acid Variability Among CHO Media")
Surveying Amino Acid Variability Among CHO MediaVariability in amino acid levels across CHO media can affect growth and product quality. Learn why real-time monitoring and proactive control strategies are key to improving process consistency.
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![GettyImages-517743498-bioreactor-cell-culture-screen-digital]( "Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool")
Seamless Process Transfer Using An In Silico Bioreactor Scaling ToolTransferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.
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![pharma-manufacturing-reg-GettyImages-1409457755]( "USP <665> Becomes Official On May 1, 2026. Are You Ready?")
USP <665> Becomes Official On May 1, 2026. Are You Ready?With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.
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![GettyImages-164198023-scientist-laboratory-pipette-cell-line]( "The Value Of Human Panel Testing Downstream Of Donor Screening In The Allogeneic Therapy Pipeline")
The Value Of Human Panel Testing Downstream Of Donor Screening In The Allogeneic Therapy PipelineAllogeneic cell-based therapies require rigorous donor screening for adventitious viruses. qPCR-based assays enhance detection accuracy, sensitivity, and specificity, supplementing serological testing to ensure safer drug development and production.
NEWSLETTER ARCHIVE
- 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
- 07.14.26 -- STREAM Edition: The Facility Master Planning Playbook With Herman Bozenhardt
- 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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