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

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

Innovator Insight

Unlocking advanced strategies in cell therapy analytics

Unlocking advanced strategies in cell therapy analytics

S Krause, K Shum, A Chandran et al.

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.

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.

Commentary

Cell therapy analytics and CMC: balancing innovation with standardization

Cell therapy analytics and CMC: balancing innovation with standardization

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?

Journal 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

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.

Strategic human raw material selection for cell therapy manufacturing

Strategic human raw material selection for cell therapy manufacturing

Daniel Benitez-Ribas

Advancing AAV genome integrity assessment with digital PCR

Advancing AAV genome integrity assessment with digital PCR

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

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

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

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

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

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

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.

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

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.

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