I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.
- You Can't CAPA What You Can't Classify
- New USP Guidelines, Standards Address Lentivirus Characterization
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Bringing Next-Gen Sequencing To GMP Scale
- Risk Managing Through The Void Of ATMP Visible Particle Guidance
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Promise Of MRD-Guided CAR-T Treatment
- CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cell-gene-therapy-GettyImages-2157300524]( "Direct Cell Lysis Enables Rapid And Robust Vector Copy Number (VCN) Quantification Using QIAcuity Digital PCR")
Direct Cell Lysis Enables Rapid And Robust Vector Copy Number (VCN) Quantification Using QIAcuity Digital PCRExplore a faster approach to vector copy number measurement that replaces DNA extraction with direct cell lysis and digital PCR, delivering accurate, reproducible results across fresh and frozen samples.
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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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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
Improve Speed To Market By Mitigating Vial And Stopper IncompatibilityThese studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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![Supply Chain Management GettyImages-1304746031]( "The Unique Challenges Of The Cell & Gene Therapy Supply Chain")
The Unique Challenges Of The Cell & Gene Therapy Supply ChainCell and gene therapies present unique logistical challenges for the supply chain, requiring careful consideration of factors like shelf life, packaging, temperature, and chain of custody.
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![Esco - DFB still]( "When To Consider Material And Personnel Airlocks For Downflow Booths")
When To Consider Material And Personnel Airlocks For Downflow BoothsStrategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
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![GettyImages-2193144544-scientist-cell-culture-in-lab]( "Exploring The Future Of Cell Expansion In Cell Therapy Manufacturing")
Exploring The Future Of Cell Expansion In Cell Therapy ManufacturingAs cell therapy scales, success depends on more than clinical promise. Smarter expansion strategies, automation, and flexible manufacturing platforms are becoming critical for improving consistency.
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![GettyImages-538032878 t-cell]( "12-Day Stability Of PRIME-XV T Cell Expansion Supplemented With CTGrade GMP Cytokines")
12-Day Stability Of PRIME-XV T Cell Expansion Supplemented With CTGrade GMP CytokinesDiscover how T-cell culture media supplemented with key cytokines can maintain full functionality and support robust expansion for up to 12 days at room temperature.
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![iStock-899483138 lab freeze cold 450x300.jpg]( "A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers")
A Comparative Analysis Between Liquid Nitrogen And Mechanical FreezersExplore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
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![GettyImages-1067806062-scientist-lab-vaccine-vial]( "Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis")
Quality Assurance In IVT RNA Vaccine Development Using ElectrophoresisDiscover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
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![GettyImages-1346675513 lab materials]( "Criteria For Effective Bioprocess Scale-Up")
Criteria For Effective Bioprocess Scale-UpDiscover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.
NEWSLETTER ARCHIVE
- 09.22.26 -- Balancing Innovation With Manufacturability When Designing Next Generation Vectors
- 09.22.26 -- How Regeneron Navigates Early Cell And Gene Therapy Quality Risks
- 09.21.26 -- CDMO Market Risk Report: Tracking Client M&A, Approvals, And FDA Rejections
- 09.18.26 -- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- 09.17.26 -- Navigating Digital Platforms For Smarter CDMO Selection
- Inside Kyverna's Autoimmune CAR T Platform Beyond SPS
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology
- In Vivo CAR T Needs More Than Better Cell Engineering
- Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
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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