BioInsights - Vol 6 Issue 2

CELL & 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
Focus: Global cell and gene therapy supply chain strategies at commercial scale
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
Co-sponsor Co-sponsor

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 <em>N</em>-acetyl-L-cysteine and <em>N,N’</em>-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

A Gowda, A Schaefer, T 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

D DiGiusto, R Ouro-Djobo, U 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 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

K Kime, J Denham, C 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

D Clarke, C Good, A 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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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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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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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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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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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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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
4 May 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

K Kime, J Denham, C Bravery
27 April 2020
Watch
Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturing

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

D DiGiusto, B Leistler, T Walls
13 April 2020
Watch

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

Overcoming raw material challenges in cell & gene therapy manufacturing

D DiGiusto, B Leistler, T Walls
27 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

K Kime, J Denham, C Bravery
27 April 2020
Read

Supply Chain FOCUS

Global cell and gene therapy supply chain strategies at commercial scale

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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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
Listen

Journal articles

Editorial

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

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

Jude Samulski, 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