Cell and Gene Therapy Insights Volume 11 Issue 10

CELL AND GENE THERAPY INSIGHTS

Volume 11 Issue 10

Cell and Gene Therapy Insights Volume 11 Issue 10

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Featuring

Issue Spotlight: Cell therapy analytics and CMC
Vectors focus: Characterization and Validation
Other articles
Webinars

Cell therapy analytics and CMC

Ashish Saksule

Guest Editor:

Ashish Saksule, Principal Scientist and Core Lead at Vertex Pharmaceuticals

Foreword

Cell & Gene Therapy Insights—cell therapy analytics and CMC edition

Cell & Gene Therapy Insights—cell therapy analytics and CMC edition

10 December 2025

Expert Insight

Options for using optical microscopy in the development and manufacturing of iPSCs

Options for using optical microscopy in the development and manufacturing of iPSCs

Anthony Asmar, Anne Plant

9 December 2025

Innovator Insight

Scaling smarter: a case study in overcoming cell therapy manufacturing and regulatory hurdles

Scaling smarter: a case study in overcoming cell therapy manufacturing and regulatory hurdles

18 December 2025

Unlocking advanced strategies in cell therapy analytics

Unlocking advanced strategies in cell therapy analytics

S Krause, K Shum, A Chandran et al.

8 December 2025

Genetic integrity testing of genome-edited pluripotent stem cell lines used for cell therapy applications

Genetic integrity testing of genome-edited pluripotent stem cell lines used for cell therapy applications

P Hublitz, V Patel, H Philippon et al.

26 November 2025

Regulatory perspective

Understanding GLP and cGMP regulatory framework for cell-based products to support early-phase clinical trials

Understanding GLP and cGMP regulatory framework for cell-based products to support early-phase clinical trials

A Jankelow, S R Bauer, G Almeida-Porada et al.

5 November 2025

Commentary

Cell therapy analytics and CMC: balancing innovation with standardization

Cell therapy analytics and CMC: balancing innovation with standardization

5 November 2025

Characterization and Validation

Viewpoint

What do product-specific CQAs tell us about rAAV-based in vivo gene therapy products?

What do product-specific CQAs tell us about rAAV-based in vivo gene therapy products?

21 October 2025

articles

Innovator Insight

Development and scale-up of a transient transfection rAAV process from bench scale to a next-generation, single-use bioreactor system

Development and scale-up of a transient transfection rAAV process from bench scale to a next-generation, single-use bioreactor system

Kelly Cybulski, Kyle Burrell

4 December 2025

De-risking clinical trials and enabling innovation: key strategies for empowering emerging biotechs

De-risking clinical trials and enabling innovation: key strategies for empowering emerging biotechs

A Moore, L Timmerman, J Gordon et al.

2 December 2025

Strategic human raw material selection for cell therapy manufacturing

Strategic human raw material selection for cell therapy manufacturing

Daniel Benitez-Ribas

12 November 2025

Advancing AAV genome integrity assessment with digital PCR

Advancing AAV genome integrity assessment with digital PCR

11 November 2025

FastFacts

Cryo-processed leukapheresis using an automated closed system: a high-quality starting material for autologous and allogeneic CAR-T cell therapy manufacturing

Cryo-processed leukapheresis using an automated closed system: a high-quality starting material for autologous and allogeneic CAR-T cell therapy manufacturing

Alexandre Michaux

26 November 2025

Interview

Bringing gene therapy to the brain: Cardiff’s role in the landmark Huntington’s trial

Bringing gene therapy to the brain: Cardiff’s role in the landmark Huntington’s trial

1 December 2025

CRISPR in action: inside the first genome-wide NK cell screen and what it means for immunotherapy

CRISPR in action: inside the first genome-wide NK cell screen and what it means for immunotherapy

Alexander Biederstädt

21 October 2025

Industry Insights

Industry Insights: Unpacking the FDA’s plausible mechanism pathway, regulatory turbulence, and progress in autoimmune cell therapy

Industry Insights: Unpacking the FDA’s plausible mechanism pathway, regulatory turbulence, and progress in autoimmune cell therapy

Abigail Pinchbeck

10 December 2025

Residual DNA testing: enhancing efficiency and regulatory compliance

Residual DNA testing: enhancing efficiency and regulatory compliance

Shriya Sahu

Accelerated cell therapy manufacturing with optimized microbial quality control

Accelerated cell therapy manufacturing with optimized microbial quality control

Juliana Gutierrez, Roisin McGuigan

21 October 2025

Organ-on-chip innovation: modeling the complex tumor microenvironment for drug discovery

Organ-on-chip innovation: modeling the complex tumor microenvironment for drug discovery

T Sommermann, A Deipenbrock, N Teusch

23 October 2025

Collection to commercialization: is standardization the bottleneck or breakthrough for cell and gene therapy

Collection to commercialization: is standardization the bottleneck or breakthrough for cell and gene therapy

D Fink, K Carlisle, A Greenberg et al.

4 November 2025

Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Tailoring viral clearance study design to development phase, modality, and regulatory requirements

Kathleen Kenney

5 November 2025

Collaboration in action: decentralized manufacturing to expand patient access in cell therapy

Collaboration in action: decentralized manufacturing to expand patient access in cell therapy

L Buckler, I Gaudet, A Bryan et al.

13 November 2025