Vol 6 Issue 2

CELL AND GENE THERAPY INSIGHTS

March 2020 Issue

Vol 6 Issue 2

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Featuring

Issue Spotlight: Raw and starting materials: troubleshooting supply, management and optimisation issues
Global cell and gene therapy supply chain strategies at commercial scale 2020
Other articles
Webinars

SPOTLIGHT

Raw and starting materials: troubleshooting supply, management and optimisation issues
Steven Goodman
Guest Editor:
Steven Goodman, Senior Director, Drug Product Manufacturing at bluebird bio, Inc

Foreword

Raw and Starting Materials – Foreword

Raw and Starting Materials – Foreword

Steven Goodman
8 April 2020
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Editorial

Assessing and managing raw material risk

Assessing and managing raw material risk

Tom Walls
1 April 2020
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Research Article

A simple RP-HPLC method for the stability-indicating determination of N-acetyl-L-cysteine and N,N’-diacetyl-L-cystine in cell culture media

A simple RP-HPLC method for the stability-indicating determination of N-acetyl-L-cysteine and N,N’-diacetyl-L-cystine in cell culture media

AS Prakasha Gowda, Andrew Schaefer, Terry Schuck
8 April 2020
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Expert Insight

Developing and implementing a supply chain management system for cellular therapy programs

Developing and implementing a supply chain management system for cellular therapy programs

David L DiGiusto, Rakib Ouro-Djobo, Uzair Rajput
9 April 2020
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Considerations on impact of raw material variability in gene therapy manufacturing: applying lessons learned from biologics manufacturing

Considerations on impact of raw material variability in gene therapy manufacturing: applying lessons learned from biologics manufacturing

A Mack, T Matthews, B St. Germain et al.
8 April 2020
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Innovator Insight

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials - ANIMATION

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials - ANIMATION

Kasey Kime, Jerrod Denham, Christopher Bravery
6 October 2020
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Ensuring source material consistency & continuity for commercialization of advanced therapies

Ensuring source material consistency & continuity for commercialization of advanced therapies

Dominic Clarke, Christopher Good, Amy Shaw
27 April 2020
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Improving the quality cell yield of T-cell immunotherapies through selective pressures imparted by culture media supplements

Improving the quality cell yield of T-cell immunotherapies through selective pressures imparted by culture media supplements

A Klarer, H Steidinger, A Taylor et al.
8 April 2020
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Expert Roundtable Video

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials – on demand webinar

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials – on demand webinar

Kasey Kime, Jerrod Denham, Christopher Bravery
26 April 2020
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Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturing

Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto, Bernd Leistler, Tom Walls
13 April 2020
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Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

Overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto, Bernd Leistler, Tom Walls
26 April 2020
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Commentary

The role of raw materials in the manufacturing of cell and gene therapy medicinal products: practices and challenges

The role of raw materials in the manufacturing of cell and gene therapy medicinal products: practices and challenges

José Caraballo
9 April 2020
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Podcast

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture – Podcast

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture – Podcast

Hélène Pora
3 May 2020
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Interview

Meeting the evolving challenges of media supply to the cell and gene therapy space

Meeting the evolving challenges of media supply to the cell and gene therapy space

Jason C Lin
20 April 2020
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Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture

Hélène Pora
9 April 2020
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Raw material qualification and optimization: the Janssen approach

Raw material qualification and optimization: the Janssen approach

Lili Belcastro
9 April 2020
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Optimizing and standardizing apheresis: critical next steps for the cell therapy industry

Optimizing and standardizing apheresis: critical next steps for the cell therapy industry

Joseph M Roig
1 April 2020
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Regulatory Insight

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials

Kasey Kime, Jerrod Denham, Christopher Bravery
26 April 2020
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Supply Chain FOCUS

Global cell and gene therapy supply chain strategies at commercial scale 2020

Expert Insight

Supply chain challenges and issues facing the autologous cell manufacturing industry

Supply chain challenges and issues facing the autologous cell manufacturing industry

K Wang, B Wang, C White et al.
23 April 2020
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Podcast

Enabling clinical development of cell and gene therapies on a global basis - Podcast

Enabling clinical development of cell and gene therapies on a global basis - Podcast

B Fletcher, T Joeckel, M Lachs et al.
20 April 2020
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Interview

Best practice for raw materials management on a global basis

Best practice for raw materials management on a global basis

Stephane Lameynardie
24 April 2020
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Enabling clinical development of cell and gene therapies on a global basis

Enabling clinical development of cell and gene therapies on a global basis

20 April 2020
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Journal articles

Editorial

Curing ultra-rare diseases while ensuring access, equity and affordability

Curing ultra-rare diseases while ensuring access, equity and affordability

Laura Hameed
19 March 2020
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Expert Insight

Durable and curative responses in heart disease: promises and practicalities

Durable and curative responses in heart disease: promises and practicalities

Gabor Foldes, Vasiliki E Kalodimou
17 March 2020
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Interview

ATMP innovation in liver disease

ATMP innovation in liver disease

Anil Dhawan
25 March 2020
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Current and future directions for dendritic cell vaccines

Current and future directions for dendritic cell vaccines

Gerard Bos
23 March 2020
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Webinars