Vol 8 Issue 6

CELL AND GENE THERAPY INSIGHTS

Vol 8 Issue 6

Cell and Gene Therapy Insights Vol 8 Issue 6

Download PDF

Featuring

Issue Spotlight: Global regulatory update
Driving the digitization of cell and gene therapy supply chains 2022
Other articles
Webinar

Global regulatory update

Alexis Cockroft

Guest Editor:

Alexis Cockroft, Regulatory Consultant at Lex Regulatory Ltd

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

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

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

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

Trends in academic ATMP development & manufacture in Europe

Trends in academic ATMP development & manufacture in Europe

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

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

Robert Pietrusko

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

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

Driving the digitization of cell and gene therapy supply chains 2022

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

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

FastFacts

Cell & Gene therapy supply chain orchestration explained

Cell & Gene therapy supply chain orchestration explained

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

Innovator Insight

Manufacturing considerations underpinning viral and non-viral platform selection

Manufacturing considerations underpinning viral and non-viral platform selection

A Hagerman, A Noyes, V Slepushkin et al.

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

Bruce Greenwald, Sean Chang, Krish Roy

International differences in cellular starting material quality and regulatory requirements

International differences in cellular starting material quality and regulatory requirements

B Kuker, P Machalik, S Ahmed et al.