Vol 5 Issue 7

CELL AND GENE THERAPY INSIGHTS

July 2019 Issue

Vol 5 Issue 7

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Featuring

Issue Spotlight: Meeting Preclinical Data Requirements For Cell & Gene Therapies
Suspension Culture Methods 2019
Other articles

SPOTLIGHT

Meeting Preclinical Data Requirements For Cell & Gene Therapies

Editorial

Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?

Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?

Lincoln Tsang
22 July 2019
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Preclinical requirements for cell and gene therapies

Preclinical requirements for cell and gene therapies

Carlos R Plata-Salaman
22 July 2019
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Expert Insight

Blood–brain barrier models in pre-clinical assessment of CNS-targeting cell and gene therapies

Blood–brain barrier models in pre-clinical assessment of CNS-targeting cell and gene therapies

Danica B Stanimirovic, Anna Jezierski
22 July 2019
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Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures

Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures

P Salmikangas, P Chamberlain, B Silva Lima et al.
22 July 2019
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Building a better CAR: emerging high-throughput <em>in vitro</em> tools for CAR selection and optimization

Building a better CAR: emerging high-throughput in vitro tools for CAR selection and optimization

Darin Bloemberg, Scott McComb, Risini Weeratna
22 July 2019
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Perspective

Should cell- and gene-therapy developers engage with regulatory authorities?

Should cell- and gene-therapy developers engage with regulatory authorities?

James W McBlane
22 July 2019
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Broadly-applicable imaging platforms are necessary for optimizing cell therapies in solid tumors

Broadly-applicable imaging platforms are necessary for optimizing cell therapies in solid tumors

M Srinivas, C Mann, A Andreu et al.
22 July 2019
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Interview

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Shawna M Jackman, Lauren Black
2 September 2019
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Strategic & regulatory insights for gene therapy preclinical-clinical translation in CNS

Strategic & regulatory insights for gene therapy preclinical-clinical translation in CNS

Karen Kozarsky
22 July 2019
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From NCATS to NASA: the extraordinary potential of tissue chips

From NCATS to NASA: the extraordinary potential of tissue chips

Lucie Low
22 July 2019
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Podcast

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Shawna M Jackman, Lauren Black
19 August 2019
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Regulatory Insight

Preclinical considerations for assessment of cellular & gene therapy products: FDA perspective

Preclinical considerations for assessment of cellular & gene therapy products: FDA perspective

Gaya Hettiarachchi, Wei Liang
22 July 2019
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Vectors FOCUS

Suspension Culture Methods 2019

Innovator Insight

Upstream and downstream solutions for AAV manufacturing

Upstream and downstream solutions for AAV manufacturing

J Rooij, J DeConto, G Schaenzler et al.
27 August 2019
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Expert Insight

Viral vector manufacturing: how to address current and future demands?

Viral vector manufacturing: how to address current and future demands?

Fernanda Masri, Sven Ansorge
6 August 2019
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Interview

Pros and cons of suspension culture systems in LVV upstream bioprocessing

Pros and cons of suspension culture systems in LVV upstream bioprocessing

Nolan Sutherland
6 August 2019
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Journal articles

Interview

From the get-go: how to ensure your organization is built with harnessing data in mind

From the get-go: how to ensure your organization is built with harnessing data in mind

Darshan Patel, Jarrod Lefton, Hubert Sun
25 July 2019
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Keys to successful supply chain data management for T-cell immunotherapy

Keys to successful supply chain data management for T-cell immunotherapy

Charles Wilfong, Dan Lowther
25 July 2019
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Supply chain data management and integration: process development and manufacturing

Supply chain data management and integration: process development and manufacturing

Jordan Croteau
25 July 2019
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Commercial Insights

Cell & Gene Therapy Commercial Insight – June 2019

Cell & Gene Therapy Commercial Insight – June 2019

Mark Curtis, Richard Philipson
23 July 2019
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