Industry Insights
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Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26
1/9/2026
Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.
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Metrics, Not Audits, Should Lead Vendor Accountability
1/9/2026
Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.
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Global Shifts And Strategic Resilience Will Shape CGT In 2026
1/7/2026
Dr. Miguel Forte, CEO of Kiji Therapeutics and President of ISCT, and Ali Pashazadeh, Founder of Treehill Partners share why CGT developers are now navigating a landscape defined not only by technological innovation but also by geography, regulatory agility, and investment dynamics.
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Sales & Operations Planning for Small Teams: Aligning Clinical Supply
1/6/2026
Small clinical teams don’t fail at S&OP from missing systems—they fail from unclear demand and decisions. Alignment comes from discipline, shared visibility, and acting on reality before timelines slip.
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2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
1/5/2026
2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.
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A Deeper Look At Pharma's Structural Supply Chain Vulnerability
12/31/2025
Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
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Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform
12/29/2025
The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.
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Harnessing Mitochondria: A New Frontier In Therapeutic Innovation
12/26/2025
What if we can replace damaged mitochondria with young and healthy mitochondria? In recent years, a new therapeutic field has evolved: mitochondrial transplantations.
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In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
12/23/2025
By injecting lipid-based nanoparticles encapsulating mRNA and encoding the CAR directly into the bloodstream, developers can effectively reprogram the patient's own immune cells in situ.
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CGT Industrialization Starts With CDMO Alignment
12/19/2025
Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.