Scale-up/-out of cell and gene therapy manufacturing

CELL AND GENE THERAPY INSIGHTS

September 2025

Scale-up/-out of cell and gene therapy manufacturing

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Expert Insight

Tumor-infiltrating lymphocyte therapies: personal, powerful, with possibilities for improvement

Tumor-infiltrating lymphocyte therapies: personal, powerful, with possibilities for improvement

Sergio Ribeiro, Therese Choquette

Innovator Insight

Overcoming CMC hurdles in TIL therapy: strategic insights from a clinical-stage biotech

Overcoming CMC hurdles in TIL therapy: strategic insights from a clinical-stage biotech

Alex Lei, Sabrina Carmichael

AAV production and purification: key steps from design to GMP readiness

AAV production and purification: key steps from design to GMP readiness

G Ganjam, E Jackson-Holmes, F Leseigneur et al.

Commentary

People, not platforms: the real limit to cell and gene therapy scale-up in Europe

People, not platforms: the real limit to cell and gene therapy scale-up in Europe

A Miller, E Lombardo, J Kirby et al.

FastFacts

Temperature matters: fluid management for cell-based applications

Temperature matters: fluid management for cell-based applications

Jonathan Haider

Viewpoint

Scale-up and scale-out of extracellular vesicle production utilizing industrial grade bioreactors

Scale-up and scale-out of extracellular vesicle production utilizing industrial grade bioreactors

J Ene, F Syed, J Guan et al.

Bridging preclinical to commercial manufacturing in cell therapy: mind the gap

Bridging preclinical to commercial manufacturing in cell therapy: mind the gap

Ashwin Srinivasan Kumar, Sabry Hamza, Jaichandran Sivalingam

Time for the FDA and industry–academia partnerships to invest in fully automated, quality-controlled, scale-out of autologous cell and gene therapies

Time for the FDA and industry–academia partnerships to invest in fully automated, quality-controlled, scale-out of autologous cell and gene therapies

Avoiding slowdowns on the cell and gene therapy development pathway

Avoiding slowdowns on the cell and gene therapy development pathway

William E Janssen, Scott R Burger

Event Preview

Biologics CDMO Europe 2025

Biologics CDMO Europe 2025

Webinars

Streamline disease modeling and therapeutic discovery with targeted viral vectors

Streamline disease modeling and therapeutic discovery with targeted viral vectors

Abhilasha Gupta

Integrating microbubbles into a CAR-T workflow: more doses in a smaller footprint

Integrating microbubbles into a CAR-T workflow: more doses in a smaller footprint

Alex Sargent, Crisha Christensen

Achieving high yield and purity in lentiviral production using dPCR and IEX membranes

Achieving high yield and purity in lentiviral production using dPCR and IEX membranes

Jae Hwang, Oxana M Tsygankova

Automating iPSC culture: scalable workflows

Automating iPSC culture: scalable workflows

Sophia Borate, Nathan Frank

Unlock advanced strategies in cell therapy analytics

Unlock advanced strategies in cell therapy analytics

S Peterson, K Shum, A Chandran et al.

Managing raw material changes in cell & gene therapy: ensuring compliance and consistency

Managing raw material changes in cell & gene therapy: ensuring compliance and consistency

J King-Hart, M Mendicino, K Kime et al.

Enabling scalable CAR-T therapies with next-gen animal component-free T cell media

Enabling scalable CAR-T therapies with next-gen animal component-free T cell media

Pedro Azevedo Da Silva Couto, Rukmini Ladi

Avoiding the pitfalls: 5 lessons for cell therapy manufacturing success

Avoiding the pitfalls: 5 lessons for cell therapy manufacturing success

Joseph Garrity

Automating autologous CAR T manufacturing: Timing, technology transfer and the future of operational efficiency

Automating autologous CAR T manufacturing: Timing, technology transfer and the future of operational efficiency

M Hewitt, M Parvizi, E Stone