Gene therapy analytics and CMC

CELL AND GENE THERAPY INSIGHTS

July 2024

Gene therapy analytics and CMC

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Innovator Insight

Quantitative analysis of lipids and nucleic acids in lipid nanoparticles using monolithic column

Quantitative analysis of lipids and nucleic acids in lipid nanoparticles using monolithic column

N Pavlin, M Bavčar, T Kovačič et al.

Overcoming challenges in gene therapy analytics

Overcoming challenges in gene therapy analytics

Anthony J Blaszczyk, Ana Carreras González

Regulatory perspective

Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)

Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)

S Beattie, N Lambot, J Awigena-Cook et al.

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Interview

Exploring analytical assays and CMC challenges for viral vector-based therapies

Exploring analytical assays and CMC challenges for viral vector-based therapies

Vladimir Slepushkin

Advancing the analytical toolkit to drive viral gene delivery

Advancing the analytical toolkit to drive viral gene delivery

Chelsea Amstuz, Itzcoatl Pla

Navigating gene therapy QC: exploring the expanding AAV vector analytical toolkit

Navigating gene therapy QC: exploring the expanding AAV vector analytical toolkit

Conference Insight

Global perspectives for cellular and gene therapy development and regulatory expectations: a conference report from the 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies

Global perspectives for cellular and gene therapy development and regulatory expectations: a conference report from the 2023 NIFDS-PMDA-USP Workshop for Advanced Therapies

B Clarke, M Kim, Y Sato et al.

Webinars

Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Quadplex dPCR as a tool to analyze genome integrity and heterogeneity in gene therapy drug products

Ryan Massopust

Control your AAV titers with in-line UV-Vis analysis and PAT-Driven UF/DF systems

Control your AAV titers with in-line UV-Vis analysis and PAT-Driven UF/DF systems

Brandon Goldberg

Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture

Leveraging dPCR for residual DNA and viral titer quantitation in advanced therapy manufacture