BioInsights - Vol 5 Issue 7

CELL & GENE THERAPY INSIGHTS

Vol 5 Issue 7

Cell & Gene Therapy Vol 5 Issue 7

Featuring

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

Meeting Preclinical Data Requirements For Cell & Gene Therapies

Guest Editor:

Carlos Plata Salaman, CSO, CMO & Head, R&D

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

Preclinical requirements for cell and gene therapies

Preclinical requirements for cell and gene therapies

Carlos R Plata-Salaman

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

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 Lima et al.

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

D Bloemberg, S McComb, R Weeratna

Perspective

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

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

James W McBlane

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.

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

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

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

Karen Kozarsky

From NCATS to NASA: the extraordinary potential of tissue chips

From NCATS to NASA: the extraordinary potential of tissue chips

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

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

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.

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

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

Journal articles

Commercial Insights

Cell & Gene Therapy Commercial Insight – June 2019

Cell & Gene Therapy Commercial Insight – June 2019

Mark Curtis, Richard Philipson