In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
- Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
- Pharmacogenomics In Oncology: A Pharmacokinetic Perspective
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
- Building A Self-Driving Lab For LNP Development
- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
- Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors
- Addressing The Particulate Challenge In Cell Therapy Products
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1181392775 lab, research]( "Navigating The Cell And Gene Regulatory Landscape")
Navigating The Cell And Gene Regulatory LandscapeNavigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
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![mRNA GettyImages-1428646288]( "Suitability Testing For IVT mRNA Analysis")
Suitability Testing For IVT mRNA AnalysisAutomated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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![GettyImages-1309776504-viral-inspection-laboratory-scientists]( "ADC Manufacturing: Practices, Challenges, And The Road Ahead")
ADC Manufacturing: Practices, Challenges, And The Road AheadADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.
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![cancer cell-tumor-GettyImages-1168181061]( "AI Unveils Tumor-Immune Landscape In Colorectal Adenocarcinoma")
AI Unveils Tumor-Immune Landscape In Colorectal AdenocarcinomaAI-powered multiplexed imaging and analysis explore the tumor-immune microenvironment in colorectal adenocarcinoma, identifying potential biomarkers for therapeutic insights.
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![GettyImages-1159433153-microscope-scientist-cell-culture]( "High-Throughput Screening Of Ion Channel Variants Using Automated Patch Clamp Recordings In Assay Ready Cells")
High-Throughput Screening Of Ion Channel Variants Using Automated Patch Clamp Recordings In Assay Ready CellsHigh-throughput screening of KCNQ2 ion channel variants provides insights into epilepsy and treatment responses. This validated method supports rapid characterization for precision medicine.
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![GettyImages-1346675635-laboratory-analysis-research-microscope]( "Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation")
Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With AutomationGrowing oligonucleotide complexity is straining traditional analytical workflows. See how automated LC‑UV‑MS processing offers a scalable way to boost throughput and reduce manual effort.
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![Monoclonal antibody MAB GettyImages-1294461540]( "Optimize Your Approach To mAb Development")
Optimize Your Approach To mAb DevelopmentTo meet the growing demand for mAbs and their variants, it is important to leverage opportunities for optimization as well as work with suppliers that have the resources to help your workflow thrive.
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![Research laboratory microscope-GettyImages-1564542843]( "Comparing In-Line Vs At-Line Variable Pathlength Tech For UF/DF")
Comparing In-Line Vs At-Line Variable Pathlength Tech For UF/DFDiscover how rapid amino acid profiling improves media insight, detects variability, and supports real-time optimization for stronger bioprocess control, as well as strategies to reduce risk.
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![GettyImages-1185624320-scientist-lab-smiling]( "Can Your Biopharma Team Keep Unplanned Downtime At Bay?")
Can Your Biopharma Team Keep Unplanned Downtime At Bay?Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.
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![GettyImages-158649166 assay]( "Commercial Success Starts With A Fit-For-Purpose Flow Cytometer")
Commercial Success Starts With A Fit-For-Purpose Flow CytometerDiscover how standardizing reagents and automating flow cytometry workflows can improve reproducibility, reduce troubleshooting, and accelerate progress in cell-based therapies.
NEWSLETTER ARCHIVE
- 07.29.26 -- Key Considerations for Combination Product Development
- 07.29.26 -- Full FDA Approval For TECELRA Is More Than A Regulatory Win For Solid Tumors
- 07.28.26 -- STREAM Edition: Future CGT Manufacturing Trends, AI Reality Checks, And Phase 1 Strategy
- 07.28.26 -- FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy
- 07.27.26 -- Building CGT Manufacturing Capacity For The Next Commercial Era
- Solving Vector Yield Challenges Starts Long Before Manufacturing
- 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
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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