Gene therapy analytics and CMC

CELL AND GENE THERAPY INSIGHTS

April 2025

Gene therapy analytics and CMC

Expert Insight

A structured approach to addressing leachable risk in cell and gene therapies

A structured approach to addressing leachable risk in cell and gene therapies

Innovator Insight

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

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

Marc Struhalla, Svenja Michalek

Viewpoint

A path toward universal agreement on fulfilling the need for rapid and reliable sterility assays in gene therapy

A path toward universal agreement on fulfilling the need for rapid and reliable sterility assays in gene therapy

Interview

Harnessing AI and omics for next-generation gene therapy manufacturing

Harnessing AI and omics for next-generation gene therapy manufacturing

Richard Braatz, Irene Rombel

Advancing quality standards for gene therapies: a USP perspective

Advancing quality standards for gene therapies: a USP perspective

Webinars

AAV capsid analysis and quantification with chromatography and ultracentrifugation-based techniques

AAV capsid analysis and quantification with chromatography and ultracentrifugation-based techniques

Andreja Livk, Sebastijan Peljhan

27 February 2025

Moving AAV gene therapy beyond rare disease to address large patient populations with chronic disease

Moving AAV gene therapy beyond rare disease to address large patient populations with chronic disease

Dan Oliver, Ji Hyun Lee

Achieving high-titer rAAV production with significantly reduced encapsidated host cell DNA

Achieving high-titer rAAV production with significantly reduced encapsidated host cell DNA

Ines Goncalves

Next-generation sequencing in adventitious agent testing: navigating regulatory acceptance

Next-generation sequencing in adventitious agent testing: navigating regulatory acceptance

Olaf Stamm, Horst Ruppach

Safety assays for quality control of ATMPs: improved mycoplasma detection for cell-based biotherapeutics

Safety assays for quality control of ATMPs: improved mycoplasma detection for cell-based biotherapeutics

Jens Björkman, Andreas Hecker

Making robust choices: evaluating materials in your AAV process

Making robust choices: evaluating materials in your AAV process

Michael Bodo, Birgit Rogell

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