Cell and Gene Therapy Insights Volume 10 Issue 6

Volume 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, Biologics & ATMPs Regulatory CMC Early Development Lead, Associate Director 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.

29 July 2024

Read

Overcoming challenges in gene therapy analytics

Anthony J Blaszczyk, Ana Carreras González

25 July 2024

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.

30 April 2024

Read

FastFacts

Accelerating process analytics: leveraging dPCR to quantitate AAV viral titers

Viki Mahendran

30 July 2024

Read

Interview

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

Vladimir Slepushkin

19 June 2024

Read

Advancing the analytical toolkit to drive viral gene delivery

Chelsea Amstuz, Itzcoatl Pla

18 June 2024

Read

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

Van Hoang

12 June 2024

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.

6 August 2024

Read

articles

Innovator Insight

Advancing AAV production with high-throughput screening and transcriptomics

Christopher A Reid, Markus Hörer, Mohammad A Mandegar

23 July 2024

Read

Maximizing process control and efficiency in CAR-T cell manufacturing

M Ahmadi, J Isaacson, R Jarres et al.

4 July 2024

Read

Webinar Digest

Evaluation and performance of an AAV affinity resin

Buzz Lobbezoo

9 July 2024

Read

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

M Kay Bates, W Marin, K Whitlatch

18 June 2024

Watch

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

S Shore, A Gilbert, J Bishop

20 June 2024

Watch

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

David Smith

27 June 2024

Watch

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

Sharon Rouw, Michael Brewer

3 July 2024

Watch

An automated 24-hour CAR-T manufacturing process

M Ahmadi, F Fachin, S Poh Loong

10 July 2024

Watch

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

Kunal Patel

10 July 2024

Watch

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

Brandon Goldberg

11 July 2024

Watch

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

Boris Aleynik, Mindy Miller

16 July 2024

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Navigating cold chain complexity with innovative solutions

Susan Li

17 July 2024

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

S Feldman, J Brady, D Nguyen

24 July 2024

Watch

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

Fletcher Malcom

7 August 2024

Watch

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

Maya Dubey

14 August 2024

Watch

CELL AND GENE THERAPY INSIGHTS

July 2024 Issue

Volume 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

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

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

Volume 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

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

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