BioInsights - Vol 8 Issue 06

CELL & GENE THERAPY INSIGHTS

July 2022 Issue

Vol 8 Issue 06

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Featuring

Issue Spotlight: Global regulatory update
Focus: Driving the digitization of cell and gene therapy supply chains
Other articles
Webinar

SPOTLIGHT

Global regulatory update
Alexis Cockroft
Guest Editor:
Alexis Cockroft, Regulatory Consultant at Lex Regulatory Ltd

Interview

Inside the UK’s brave new world of ATMP regulatory innovation

Inside the UK’s brave new world of ATMP regulatory innovation

Jacqueline Barry
31 July 2022
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Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

David Caulfield
9 July 2022
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Trends in academic ATMP development & manufacture in Europe

Trends in academic ATMP development & manufacture in Europe

Pauline Meij
9 July 2022
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Regulatory learnings for the next wave of cellular immuno-oncology agents

Regulatory learnings for the next wave of cellular immuno-oncology agents

Robert Pietrusko
25 June 2022
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Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Asawari Bapat
23 June 2022
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Viewpoint

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Kathleen Candando, Karl Whitney
9 July 2022
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Regulatory perspective

A need for a novel regulatory framework for individualized neoantigen-specific therapies

A need for a novel regulatory framework for individualized neoantigen-specific therapies

Amy Hardwick, Kathleen Francissen
28 June 2022
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Supply Chain FOCUS

Driving the digitization of cell and gene therapy supply chains

FastFacts

Cell & Gene therapy supply chain orchestration explained

Cell & Gene therapy supply chain orchestration explained

Andreas Göbel, Camila Mendes
16 July 2022
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Commentary

Critical success factors to consider before digitizing a cell & gene therapy supply chain

Critical success factors to consider before digitizing a cell & gene therapy supply chain

August Zepka, Charles Wilfong
22 July 2022
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Innovator Insight

Optimizing and standardizing the cryopreservation of cellular samples: new data and insights from the UK’s Advanced Therapy Treatment Centres network programme

Optimizing and standardizing the cryopreservation of cellular samples: new data and insights from the UK’s Advanced Therapy Treatment Centres network programme

Sandeep Kumar, Julie Meneghel
17 September 2022
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Journal articles

Research Article

Consideration of quality by design principles in the use of sterilizing grade filters for clarification and final sterile filtration in adeno-associated virus applications

Consideration of quality by design principles in the use of sterilizing grade filters for clarification and final sterile filtration in adeno-associated virus applications

Morven McAlister, Alexander Lambropoulos
29 August 2022
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Poster

The digital revolution: technological innovations to enable automation in cell therapy manufacturing

The digital revolution: technological innovations to enable automation in cell therapy manufacturing

B Greenwald, S Chang, K Roy
12 July 2022
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Webinars