Cell and Gene Therapy Insights Volume 12 Issue 8

CELL AND GENE THERAPY INSIGHTS

Volume 12 Issue 8

Cell and Gene Therapy Insights Volume 12 Issue 8

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Featuring

Issue Spotlight: Manufacturing scale-up/scale-out and automation
Translational Research & Clinical Development focus: Translational models
Other articles
Webinars

Manufacturing scale-up/scale-out and automation

Expert Insight

Education and training for the cell and gene therapy sector: initiatives, gaps and future opportunities

Education and training for the cell and gene therapy sector: initiatives, gaps and future opportunities

Gary Gilleskie, Elissa Hudspeth

ATMP development and market access in Europe and the United States: why scientific innovation alone no longer wins

ATMP development and market access in Europe and the United States: why scientific innovation alone no longer wins

Jens Kurth , Günter Harms

Review

Hidden translation costs in cell and gene therapy manufacturing

Hidden translation costs in cell and gene therapy manufacturing

Robert E Nordon

Innovator Insight

Evaluation of ice recrystallization inhibitors for preserving the post-thaw function of iPSC-derived natural killer cells

Evaluation of ice recrystallization inhibitors for preserving the post-thaw function of iPSC-derived natural killer cells

Anna Jezierski, Robert N Ben

Scale-up and process transfer considerations in lentiviral vector manufacturing

Scale-up and process transfer considerations in lentiviral vector manufacturing

Jonathan Zmuda, Shin Kawamata

Infographic

End-to-end CAR-T manufacturing workflow

End-to-end CAR-T manufacturing workflow

Cell processing in cell therapy manufacturing

Cell processing in cell therapy manufacturing

Accelerating AAV biosafety testing to 1–2 weeks with validated NGS workflows

Accelerating AAV biosafety testing to 1–2 weeks with validated NGS workflows

Andrew Hillhouse

Interview

Building an autologous CAR-T manufacturing network from scratch: infrastructure, workforce, and what comes next

Building an autologous CAR-T manufacturing network from scratch: infrastructure, workforce, and what comes next

Frederik Buysse

From feasibility to access: how is cell therapy’s central challenge evolving?

From feasibility to access: how is cell therapy’s central challenge evolving?

Christian Chabannon

Tech Showcase

Unlocking high-yield, cost-efficient EV manufacturing through fixed-bed bioreactors

Unlocking high-yield, cost-efficient EV manufacturing through fixed-bed bioreactors

Rapid, simple purification of AAV using low-speed centrifugation

Rapid, simple purification of AAV using low-speed centrifugation

Michael Dzuricky

Translational models

Interview

Reprogramming the neighborhood: how a soluble factor shields pancreatic tumors from CAR-T cells

Reprogramming the neighborhood: how a soluble factor shields pancreatic tumors from CAR-T cells

William Matsui, Bryan McClellan

articles

Innovator Insight

Characterizing extracellular vesicles across analytical and process development

Characterizing extracellular vesicles across analytical and process development

Infographic

Only two in ten eligible patients receive CAR-T: closing the gap starts in manufacturing

Only two in ten eligible patients receive CAR-T: closing the gap starts in manufacturing

Interview

Potency, off-target analysis, and comparability in in vivo gene-edited therapy development

Potency, off-target analysis, and comparability in in vivo gene-edited therapy development

Scaling up and scaling out: expanding patient access with in vivo CAR-T

Scaling up and scaling out: expanding patient access with in vivo CAR-T

Event Preview

Event preview of the World Orphan Drug Congress 2026

Event preview of the World Orphan Drug Congress 2026

Tech Showcase

Achieve over 98% viability and up to a 10% recovery increase in automated leukapheresis cryopreservation

Achieve over 98% viability and up to a 10% recovery increase in automated leukapheresis cryopreservation

Cell-derived nanoparticles: a new paradigm for CAR-T cell activation and manufacturing

Cell-derived nanoparticles: a new paradigm for CAR-T cell activation and manufacturing

P Moura, B Shy, K Li et al.

De-risking AAV development: from upstream optimization to regulatory-ready testing

De-risking AAV development: from upstream optimization to regulatory-ready testing

David Stewart, Jordan Magisson

Animal component-free T cell processing: A GMP-ready workflow for ex vivo cell manufacturing

Animal component-free T cell processing: A GMP-ready workflow for ex vivo cell manufacturing

Zayda L. Piedra, PhD

Delivering confidence in precision medicine: strategies for potency, safety, and long-term success

Delivering confidence in precision medicine: strategies for potency, safety, and long-term success

S Joshi MD, MBBS, L Donahue, A Lavelle, PhD et al.

Case study: real-time AAV titer monitoring validated against ddPCR and immunoassay

Case study: real-time AAV titer monitoring validated against ddPCR and immunoassay

Paul Mania, Teva Smith

Transitioning to serum-free T cell manufacturing: process considerations and cross-platform scale-up data

Transitioning to serum-free T cell manufacturing: process considerations and cross-platform scale-up data

Chengkang Zhang, PhD

From pleural T cells to patients: translating FastTIL research into first-in-human cell therapy

From pleural T cells to patients: translating FastTIL research into first-in-human cell therapy

Albert Donnenberg, PhD

From research to clinical manufacturing: advancing gene-edited HSC therapies through collaboration

From research to clinical manufacturing: advancing gene-edited HSC therapies through collaboration

S Cherqui, PhD, D S Kaufman, PhD, N Ravinder, PhD