Vol 7 Issue 9

CELL AND GENE THERAPY INSIGHTS

October 2021 Issue

Vol 7 Issue 9

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Featuring

Issue Spotlight: Gene therapy CMC and quality control
Other articles
Webinars

SPOTLIGHT

Gene therapy CMC and quality control

Foreword

Gene therapy CMC and quality control

Gene therapy CMC and quality control

Christine Le Bec
21 October 2021
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Expert Insight

Analytical toolkit for rapid formulation development of rAAV gene therapies

Analytical toolkit for rapid formulation development of rAAV gene therapies

Julie Yu Wei, Ying Cai, James Warren
22 October 2021
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Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

Challenges in AAV manufacturing: the interplay of process variations, in-process characterization, and drug product quality

D Chu, H Acharya, E Springfield et al.
21 October 2021
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The Chemistry Manufacturing and Controls (CMC) section of gene therapy-based INDs: overview in a changing landscape

The Chemistry Manufacturing and Controls (CMC) section of gene therapy-based INDs: overview in a changing landscape

Gabriela Denning, PhD
18 October 2021
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Innovator Insight

Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges

Expression systems for viral vector production: advantages of the Sf9 baculovirus system and simple solutions to address its specific analytical challenges

Yi Fang Lee, Srinath Kashi Ranganath
25 October 2021
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Interview

Advancing real-time monitoring of AAV vector processes

Advancing real-time monitoring of AAV vector processes

13 October 2021
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Next steps in the evolution of AAV vector characterization technologies

Next steps in the evolution of AAV vector characterization technologies

Eduard Ayuso
5 October 2021
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Addressing challenges in characterizing novel AAV capsids and gene editing platform-driven therapeutics

Addressing challenges in characterizing novel AAV capsids and gene editing platform-driven therapeutics

Lauren M Drouin
2 October 2021
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Podcast

Advancing real-time monitoring of AAV vector processes

Advancing real-time monitoring of AAV vector processes

Rachel Legmann, Joe Ferraiolo
11 October 2021
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Webinar Digest

Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

4 November 2021
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Journal articles

Perspective

Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

N Lambot, J Awigena-Cook, T Reimer et al.
29 September 2021
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Innovator Insight

Practical application of cell counting method performance evaluation and comparison derived from the ISO Cell Counting Standards Part 1 and 2

Practical application of cell counting method performance evaluation and comparison derived from the ISO Cell Counting Standards Part 1 and 2

Y Huang, J Bell, D Kuksin et al.
15 September 2021
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Chromatographic purification with CIMmultus™ Oligo dT increases mRNA stability

Chromatographic purification with CIMmultus™ Oligo dT increases mRNA stability

M Korenč, N Mencin, J Puc et al.
13 October 2021
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Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

Are you finishing strong in cell therapy manufacturing? Tackling your final fill and finish challenges with automation

11 November 2021
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Commentary

The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

E Bicudo, I Brass, P Carmichael et al.
30 September 2021
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Webinars