Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
- In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
- CGT Industrialization Starts With CDMO Alignment
- Powering Cell Therapies With RNA: A New Code For Engineered Immunity
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
- November 2025 — CDMO Opportunities And Threats Report
- 2025's Top 5 Drug Discovery Highlights And How To Stay Ahead In 2026
- What 2025 FDA Warning Letters Tell Us About GMP Compliance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Reliable Proliferation And Differentiation Of Desired T Cell Subpopulations
This study evaluates a cost-effective alternative to Proleukin® for expanding T cells that demonstrates comparable performance across cell viability, subpopulation ratios, and clinical consistency.
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Streamlining Compliance With Pre-Clinical Safety Tests
As cell therapies advance, challenges in ensuring safe, scalable, and compliant production increase. Discover how to develop efficient strategies to maintain cell viability and functionality throughout the supply chain.
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Automating High-Throughput Screens Using Patient-Derived Organoids
Many oncology drugs fail in later development stages due to inadequate predictive models. Explore how 3D cell models, like patient-derived organoids, offer a promising solution in the drug development process.
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Analysis Of Partial Capsids Using Empty-Full Capsid Kit
Discover how to assess AAV genome integrity beyond ITR-2 using an extended ddPCR method for precise quantification of empty and full capsids with various genomic targets.
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Performance Comparison Of The Vericheck ddPCR™ Empty-Full Capsid Kit And Analytical Ultracentrifugation (AUC)
Discover how Droplet Digital PCR (ddPCR) offers a precise analysis of AAV capsid content, outperforming analytical ultracentrifugation (AUC) in distinguishing therapeutic genomes from contaminants.
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Designing A Disinfectant Study For Your Cleanroom
Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.
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Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
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A Biosafety Cabinet For Virology Studies And Disease Surveillance
Discover how Germfree tackled a unique challenge from the Public Health Agency of Canada by designing a custom Class III biosafety cabinet for advanced virology studies and disease surveillance.
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High-Yield Expression Of Complex Proteins From Stable Pools
This study presents the development of apoptosis-resistant CHO cell lines (DKO1 and DKO2), using electroporation technology, with the goal of enhancing biotherapeutic production.
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Quality Control Of Oligonucleotides Using HPLC Coupled To UV And MS Detection
Efficient quality control of therapeutic oligonucleotides is crucial. Explore advanced methods combining HPLC-UV and mass spectrometry for precise impurity quantification and mass confirmation.
NEWSLETTER ARCHIVE
- 01.02.26 -- Building Supply Chain Resilience When Dual-Sourcing Isn't An Option
- 12.23.25 -- STREAM Edition: Engineering B Cells With Immusoft's Sean Ainsworth
- 12.23.25 -- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- 12.22.25 -- Cell & Gene Therapy Outsourcing's New Paradigm
- 12.19.25 -- Viability On The Line: Defining Minimum Quality For CGT Raw Materials
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
- CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B
- Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional
- Why Early Manufacturing Decisions in Cell & Gene Therapy Matter
- How Early Manufacturing Decisions Shape Long-Term Success
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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