Vol 10 Issue 8

CELL AND GENE THERAPY INSIGHTS

Vol 10 Issue 8

Cell and Gene Therapy Insights Vol 10 Issue 8

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Featuring

Issue Spotlight: Scale-up/scale-out of cell & gene therapy manufacturing
Other articles
Webinars

Scale-up/scale-out of cell & gene therapy manufacturing

Expert Insight

The cell therapy industrial revolution: current successes, existing challenges, and expansion into new domains

The cell therapy industrial revolution: current successes, existing challenges, and expansion into new domains

Joel Gaston, Matthew Li

Innovator Insight

Mastering AAV production: best practices for small to large-scale manufacturing success and reduced development times

Mastering AAV production: best practices for small to large-scale manufacturing success and reduced development times

Emily Jackson-Holmes

Navigating cold chain complexity to enable clinical-to-commercial transition of advanced therapies

Navigating cold chain complexity to enable clinical-to-commercial transition of advanced therapies

Viewpoint

Decentralizing gene and cell therapy manufacturing: changing tides or uphill battle

Decentralizing gene and cell therapy manufacturing: changing tides or uphill battle

Interview

Shifting to non-viral in vivo therapies to enhance global patient access to genetic medicines

Shifting to non-viral in vivo therapies to enhance global patient access to genetic medicines

Leveraging the baculovirus-insect cell expression system for optimal AAV scale-up

Leveraging the baculovirus-insect cell expression system for optimal AAV scale-up

Barbara Sanders, Femke Hoeksema

Journal articles

Expert Insight

Analytics for cell and gene therapy products in early development: points to consider before preparing an IND for a first-in-human clinical trial

Analytics for cell and gene therapy products in early development: points to consider before preparing an IND for a first-in-human clinical trial

William E Janssen, Scott Burger

Commentary

Illuminating pathways and balancing precision: maximizing economic value in breast cancer gene therapy through integrated CMC, analytics, and collaboration

Illuminating pathways and balancing precision: maximizing economic value in breast cancer gene therapy through integrated CMC, analytics, and collaboration

Arya Bhushan , Preeti Misra

FastFacts

Demystifying AAV affinity capture: mapping AAV-affinity ligand footprints with cryo-electron microscopy

Demystifying AAV affinity capture: mapping AAV-affinity ligand footprints with cryo-electron microscopy

Nathaniel Clark

Automated cryopreservation process development for leukapheresis to support supply chains

Automated cryopreservation process development for leukapheresis to support supply chains

Alexandre Michaux

Infographic

4 key lessons learnt from choosing in-house assay development

4 key lessons learnt from choosing in-house assay development

Interview

Advancing CAR-T therapies: navigating innovation, challenges, and the future of biopharma analytics

Advancing CAR-T therapies: navigating innovation, challenges, and the future of biopharma analytics

Engineering next-generation CAR-T cell therapy for cancer

Engineering next-generation CAR-T cell therapy for cancer

Yvonne Chen

Salt-tolerant endonucleases and the benefits for viral vector manufacturing, and a comparison of two marketed enzymes

Salt-tolerant endonucleases and the benefits for viral vector manufacturing, and a comparison of two marketed enzymes

Marc Struhalla, Svenja Michalek

Extracellular vesicles: setting-up the path to IND with advanced characterization packages

Extracellular vesicles: setting-up the path to IND with advanced characterization packages

Davide Zocco

Development of an automated AAV capsid titer assay on a high-throughput platform

Development of an automated AAV capsid titer assay on a high-throughput platform

Matthew J.Lotti, John Chappell

The benefits of single-use systems for enhanced process security

The benefits of single-use systems for enhanced process security

Advancing viral vector manufacturing with innovation: the importance of the cell line

Advancing viral vector manufacturing with innovation: the importance of the cell line

Marguerite Campbell, Brian Tomkowicz

Considerations in leveraging the Universal AAV Standard for dPCR to assess AAV genomes quantity and quality

Considerations in leveraging the Universal AAV Standard for dPCR to assess AAV genomes quantity and quality

Andrzej Noyszewski, Alex Deiulio

From the lab to the bench, scaling up regulatory T cell therapy

From the lab to the bench, scaling up regulatory T cell therapy

Megan K. Levings, Hany Meås

Clinical-scale non-viral gene edited CAR-NK cells for cell therapy

Clinical-scale non-viral gene edited CAR-NK cells for cell therapy

Krishanu Saha, Namritha Ravinder

Early-stage analytical development strategies for cell therapy

Early-stage analytical development strategies for cell therapy

R Mendoza, K Carter, D Kamikura et al.

Preparing for success in gene therapy purification

Preparing for success in gene therapy purification

X Fu, A Tustian, A Sharma et al.

Preparing for success in gene therapy analytical development

Preparing for success in gene therapy analytical development

Y Zhi, J Li, A Castillo

Automated cell isolation: flexibility meets performance

Automated cell isolation: flexibility meets performance

Enabling allogeneic cell therapy development: scaling up generation of PSC-derived NK cells

Enabling allogeneic cell therapy development: scaling up generation of PSC-derived NK cells

Mark Kennedy, Marcus Bunn

Unlocking success in CAR T tech transfer: from challenges to seamless execution

Unlocking success in CAR T tech transfer: from challenges to seamless execution

S Mills, N Blackburn, D Miskimin