Vol 10 Issue 6

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Featuring

Issue Spotlight: Gene therapy analytics and CMC
Other articles
Webinars

Gene therapy analytics and CMC

Guest Editor:

Stuart Beattie, Associate Director, Gene Therapy Global Regulatory CMC Clinical Lead at Biogen

Innovator Insight

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

N Pavlin, M Bavčar, T Kovačič et al.

28 July

Read

Overcoming challenges in gene therapy analytics

Anthony J Blaszczyk, Ana Carreras González

24 July

Read

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)

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

29 April

Read

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Viki Mahendran

29 July

Read

Interview

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

Vladimir Slepushkin

18 June

Read

Advancing the analytical toolkit to drive viral gene delivery

Chelsea Amstuz, Itzcoatl Pla

17 June

Read

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

Van Hoang

11 June

Read

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

B Clarke, M Kim, Y Sato et al.

5 August

Read

Journal articles

Innovator Insight

Advancing AAV production with high-throughput screening and transcriptomics

Christopher A Reid, Markus Hörer, Mohammad A Mandegar

22 July

Read

Maximizing process control and efficiency in CAR-T cell manufacturing

M Ahmadi, J Isaacson, R Jarres et al.

3 July

Read

Webinar Digest

Evaluation and performance of an AAV affinity resin

Buzz Lobbezoo

8 July

Read

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

Ryan Massopust

11 June

Watch

Specifications don’t tell the whole story: how to choose GMP process and QC equipment

M Kay Bates, W Marin, K Whitlatch

18 June

Watch

Discover the road to success for viral vector production: strategies, insights, and regulatory considerations

S Shore, A Gilbert, J Bishop

20 June

Watch

End-to-end automated manufacturing of low-seed CAR-T cells

David Smith

27 June

Watch

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Sharon Rouw, Michael Brewer

3 July

Watch

An automated 24-hour CAR-T manufacturing process

M Ahmadi, F Fachin, S Poh Loong

10 July

Watch

CAR-NK production for clinical applications using BaEV lentivirus and the NK cell engineering platform

Kunal Patel

10 July

Watch

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

Brandon Goldberg

11 July

Watch

Improving cell therapy manufacturing with on-line monitoring of critical process parameters during cell expansion

Boris Aleynik, Mindy Miller

16 July

Watch

Navigating cold chain complexity with innovative solutions

Susan Li

17 July

Watch

Development of a non-viral gene delivery platform for CAR-T manufacturing

S Feldman, J Brady, D Nguyen

24 July

Watch

Short and long-term impacts of AAV process optimization on your gene therapy pipeline

Fletcher Malcom

7 August

Watch

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

Maya Dubey

14 August

Watch

CELL AND GENE THERAPY INSIGHTS

July 2024 Issue

Vol 10 Issue 6

Featuring

SPOTLIGHT

Gene therapy analytics and CMC

Innovator Insight

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

Overcoming challenges in gene therapy analytics

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)

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Interview

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

Advancing the analytical toolkit to drive viral gene delivery

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

Journal articles

Innovator Insight

Advancing AAV production with high-throughput screening and transcriptomics

Maximizing process control and efficiency in CAR-T cell manufacturing

Webinar Digest

Evaluation and performance of an AAV affinity resin

Webinars

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

Specifications don’t tell the whole story: how to choose GMP process and QC equipment

Discover the road to success for viral vector production: strategies, insights, and regulatory considerations

End-to-end automated manufacturing of low-seed CAR-T cells

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

An automated 24-hour CAR-T manufacturing process

CAR-NK production for clinical applications using BaEV lentivirus and the NK cell engineering platform

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

Improving cell therapy manufacturing with on-line monitoring of critical process parameters during cell expansion

Navigating cold chain complexity with innovative solutions

Development of a non-viral gene delivery platform for CAR-T manufacturing

Short and long-term impacts of AAV process optimization on your gene therapy pipeline

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

CELL AND GENE THERAPY INSIGHTS

July 2024 Issue

Vol 10 Issue 6

Featuring

SPOTLIGHT

Gene therapy analytics and CMC

Innovator Insight

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

Overcoming challenges in gene therapy analytics

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)

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Interview

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

Advancing the analytical toolkit to drive viral gene delivery

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

Journal articles

Innovator Insight

Advancing AAV production with high-throughput screening and transcriptomics

Maximizing process control and efficiency in CAR-T cell manufacturing

Webinar Digest

Evaluation and performance of an AAV affinity resin

Webinars

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

Specifications don’t tell the whole story: how to choose GMP process and QC equipment

Discover the road to success for viral vector production: strategies, insights, and regulatory considerations

﻿﻿End-to-end automated manufacturing of low-seed CAR-T cells

﻿﻿Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

﻿﻿An automated 24-hour CAR-T manufacturing process

﻿﻿CAR-NK production for clinical applications using BaEV lentivirus and the NK cell engineering platform

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

Improving cell therapy manufacturing with on-line monitoring of critical process parameters during cell expansion

Navigating cold chain complexity with innovative solutions

Development of a non-viral gene delivery platform for CAR-T manufacturing

Short and long-term impacts of AAV process optimization on your gene therapy pipeline

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

End-to-end automated manufacturing of low-seed CAR-T cells

Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

An automated 24-hour CAR-T manufacturing process

CAR-NK production for clinical applications using BaEV lentivirus and the NK cell engineering platform

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