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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![Eppendorf - autosampler]( "Automated Sampling Of A Four Vessel Parallel CHO Cell Culture")
Automated Sampling Of A Four Vessel Parallel CHO Cell CultureLearn how automated sampling for parallel bioreactors enables continuous, sterile sample collection from CHO cell cultures, maintaining cell density with reduced manual intervention.
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![GettyImages-1153214501-filtration-funnel-lab]( "Microbial Recovery And Flow Performance With Membranes")
Microbial Recovery And Flow Performance With MembranesCompare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.
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![Pouching solutions]( "Pouching Solutions For Sterile And Moisture-Sensitive Devices")
Pouching Solutions For Sterile And Moisture-Sensitive DevicesAseptic pouching requires specialized mechanical segregation and sterile vacuum handling. Discover how targeted engineering maintains Grade A compliance.
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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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![GettyImages-1480473800 roadmap]( "Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success")
Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered SuccessThe commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.
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![GettyImages-1489353864-vial-mycoplasma-gloved-hand]( "Fast And Sensitive Mycoplasma Detection Workflow")
Fast And Sensitive Mycoplasma Detection WorkflowDigital PCR enables fast, sensitive mycoplasma detection in cell-based products. Explore how this pharmacopeia-compliant workflow improves accuracy, reduces delays, and supports reliable decision-making.
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![GettyImages-1142684567 cell culture]( "Consistent Improvement In CHO-K1 GS Performance With Efficient-Pro Feed 3 And Efficient-Pro Feed Enhancer")
Consistent Improvement In CHO-K1 GS Performance With Efficient-Pro Feed 3 And Efficient-Pro Feed EnhancerOptimize your CHO-K1 GS cell line with advanced chemically defined, animal origin-free feeds. Achieve higher titers and reliable product quality.
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![GettyImages-1213787059-scientist-in-laboratory-with-flasks-cell-culture]( "Reducing Cost Drivers And Improving Efficiency In CAR T Cell Manufacturing")
Reducing Cost Drivers And Improving Efficiency In CAR T Cell ManufacturingFragmented CAR T cell manufacturing workflows drive up costs and extend timelines. This case study quantifies what consolidating manufacturing and QC through automation actually delivers.
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![GettyImages-1388560078-chimeric-antigen-receptor-cell]( "Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays")
Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker AssaysReceptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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![GettyImages-1337678825-assay-well-plate-cell-culture]( "Matrigel Dome Assay And Drug Screening Of Colorectal Cancer Organoids")
Matrigel Dome Assay And Drug Screening Of Colorectal Cancer OrganoidsUsing CRC organoids and bioprinting, explore the automation of dome assays to evaluate drug responses and delve into the insights from image-based end-point assays on the efficacy of anti-cancer treatments.
NEWSLETTER ARCHIVE
- 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
- 09.16.26 -- Strategies To Boost Yield, Speed IND Timelines, And Scale AAV Manufacturing
- 09.16.26 -- Novel Approach To Cancer Explores Severing Its Genetic Supply Line
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 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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