An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
- 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
- Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions?
- A QMS That Anticipates Cell And Gene Therapy Quality Challenges
- Using Digital Platforms To Find Your CDMO
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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High-Sensitivity IVT mRNA AnalysisQuality analysis of in vitro transcribed (IVT) has become an essential part of biotherapeutic workflows. Discover a high-sensitivity kit made for analyzing IVT mRNA quality to advance your research.
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![biotech-biopharma-GettyImages-2249359729]( "Confirming Structural Consistency With HDX-MS")
Confirming Structural Consistency With HDX-MSTo support regulatory confidence, a biopharma company evaluated whether manufacturing changes affected its monoclonal antibody's higher-order structure.
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![GettyImages-1309776439-scientists-lab-analysis-manufacturing]( "Challenges And Solution In The Poly (A) Control For Plasmid And mRNA")
Challenges And Solution In The Poly (A) Control For Plasmid And mRNAPoly(A) tail integrity is critical for mRNA stability and translation. Advanced strategies optimize plasmid design, transcription, and purification to ensure consistent poly(A) control for therapeutic success.
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Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGTThis paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.
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![GettyImages-1491009758 lab, cell culture]( "Set Your Cell And Gene Therapy Program Up For Success From Day One")
Set Your Cell And Gene Therapy Program Up For Success From Day OnePartner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
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![GettyImages-2036497889-lab-computer-research]( "Transforming Clinical Trial Management")
Transforming Clinical Trial ManagementSee how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
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![GettyImages-2174865889-scientists-laboratory-equipment-analysis]( "Optimized Product Recovery Using The Drug Product Filtration System")
Optimized Product Recovery Using The Drug Product Filtration SystemExplore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.
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![woman receiving cancer treatment-GettyImages-1346190289]( "Developing Next-Generation Therapies For Breast Cancer Patients")
Developing Next-Generation Therapies For Breast Cancer PatientsBreast cancer trials span multiple subtypes and modalities. Learn how specialized oncology experience helps reduce enrollment risk and keep programs on track.
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![GettyImages-1412800224-scientist-examining-filter-in-lab]( "Sterile Filter Membrane Selection For Cell Culture Media Filtration")
Sterile Filter Membrane Selection For Cell Culture Media FiltrationMembrane design and filtration capacity affect pressure, throughput, and scale-up. See how comparative testing reveals opportunities to reduce required filtration area, capsule use, and changeouts.
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Sample Clean-Up After N-Linked Glycan Release And LabelingGlycan profiling starts with effective clean-up. See how comparable recovery across key labeled glycans and sialylated glycan groups can support confident analysis while helping labs manage costs.
NEWSLETTER ARCHIVE
- 09.15.26 -- Consequences Of Environmental Residues In Cleanrooms
- 09.15.26 -- Fixing AAV Recovery With Siren Biotechnology's Nathalie Clément, Ph.D.
- 09.15.26 -- Managing The Presence Of Visible Particulates In Cell Therapies
- 09.14.26 -- Your Collaborator: mAb Productivity And Robustness
- 09.14.26 -- How To Select The Right Manufacturing Model For Your Pipeline
- 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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