Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
- MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- Active Versus Passive Shipping Solutions For Clinical Shipments
- January 2026 — CDMO Opportunities And Threats Report
- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- Why Clinical Supply Risk Starts With Demand Signals
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Proven Supplement For CAR-T Solid Tumor Cytotoxicity
Optimize cell culture for solid tumor research. Replacing traditional serum can significantly enhance CAR-T cytotoxicity, improve consistency, and streamline the path to GMP-ready workflows.
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Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.
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Modeling Inflammation-Specific Immune Cell Recruitment
Traditional models for studying inflammatory bowel disease (IBD) often fall short. See how the Colon Intestine-Chip was used to model the progression of IBD driven by immune cells more completely.
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Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization
Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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Revolutionizing Viral Infectious Disease Research And Drug Discovery
Learn how Organ-Chips are being used to rapidly identify promising treatments, investigate virus evolution, and analyze how mechanical forces influence the innate immune response to viral infections.
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Phase 1 Clinical Trial Designs And Strategies
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals
Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.
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Virus Reduction And Impurity Removal
Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.
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Media Exchange In iPSC Cell Expansion And Differentiation: A Comparative Study
Low-shear, closed-system media exchange in iPSC differentiation is vital for scalability. This study compares automated centrifugation to gravity sedimentation, showing equivalent or superior differentiation outcomes.
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Integrated Upstream And Downstream Strategies For Robust mAb Manufacturing
Process robust mAb production requires understanding scale dependent cell environments, leveraging predictive models, and pursuing data driven control to minimize variability, optimize quality, and ensure reliable technology transfer across biomanufacturing scales.
NEWSLETTER ARCHIVE
- 02.24.26 -- STREAM Edition: CGT Regulation In 2026 Moves Toward Disciplined Flexibility And Higher Standards
- 02.24.26 -- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- 02.23.26 -- Mastering EU GMP Annex 1: Packaging, Performance, And Contamination Control
- 02.23.26 -- Ready to design a scalable, cost optimized viral vector workflow?
- 02.23.26 -- Ensuring The Raw Material Data Package Supports Regulatory Filings
- Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real
- Disciplined CGT Will Win On 2026 Regulatory Flexibility
- ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026
- Global Shifts And Strategic Resilience Will Shape CGT In 2026
- Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost
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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