The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
- Why Cell And Gene Therapies Break After Early Success
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
- Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry
- Why A Cell Therapy CEO Waited Until Phase III To Outsource
- Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- How To Implement Post-Approval Changes On A Global Level
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-931069642 mAb, monoclonal antibodies]( "Empowering Antibody Discovery With ProSpeed™")
Empowering Antibody Discovery With ProSpeed™Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.
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![GettyImages-2182054861-mab-process-capture-3d-close-up]( "Balancing Protein A Resin Cost, Performance, And Productivity")
Balancing Protein A Resin Cost, Performance, And ProductivityOptimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet your specific process requirements.
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![GettyImages-1731147638 research, cell culture]( "Enhanced mAb Production With High-Intensity Perfusion CHO Medium")
Enhanced mAb Production With High-Intensity Perfusion CHO MediumReach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
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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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![GettyImages-1293879301-scientists-inspecting-analyzing-lab]( "Improved Sensitivity In Flow Cytometry By In-Line Pre-Enrichment")
Improved Sensitivity In Flow Cytometry By In-Line Pre-EnrichmentTracking rare immune cells is no longer limited by conventional flow cytometry sensitivity. Learn how integrated pre‑enrichment strategies enable reliable detection and improved quantification.
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![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
Functional Testing Summary Of Daikyo Crystal Zenith Nested VialsThe Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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![GettyImages-1787595822-virus-viral-bacteria-cell]( "Application Of A Dual Spiking Strategy In Viral Clearance Studies")
Application Of A Dual Spiking Strategy In Viral Clearance StudiesExplore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.
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![GettyImages-1184711342-imaging-cancer-cells]( "Studying The Spatial Architecture Of Glioblastoma")
Studying The Spatial Architecture Of GlioblastomaExplore how intra-tumor heterogeneity (ITH) impacts cancer progression and therapy resistance with advanced imaging platforms and custom antibody panels to reveal the spatial architecture of glioblastoma (GBM).
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![GettyImages-1002000796-lab-research-scientist-development]( "Optimize T Cell Phenotype With One-Step Isolation And Activation")
Optimize T Cell Phenotype With One-Step Isolation And ActivationThis comparative bench-scale study features active-release beads that could improve the reliability, consistency, and longevity of cell therapy treatments.
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![Scientist clean room cell culture-GettyImages-542712102]( "Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells")
Physiologix™ Serum Replacement Performance On Mesenchymal Stem CellsLearn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.
NEWSLETTER ARCHIVE
- 04.22.26 -- Building Resilient Biomanufacturing From Media To Market
- 04.22.26 -- From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
- 04.21.26 -- All The Ways Global Biopharma Still Grapples With Annex 1
- 04.21.26 -- STREAM Edition: Bridging Analytical Gaps To Ensure CGT Material Quality
- 04.20.26 -- Why A Cell Therapy CEO Waited Until Phase III To Outsource
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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