BioInsights - Raw and starting materials - spotlight

CELL & GENE THERAPY INSIGHTS

Gary du Moulin

Guest Editor:

Gary du Moulin, Consultant in Quality Systems and Compliance Strategies

March 2022

Raw and starting materials

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Foreword

Raw & starting materials for cell and gene therapies

Raw & starting materials for cell and gene therapies

Gary du Moulin

Editorial

Managing variability in autologous apheresis collections

Managing variability in autologous apheresis collections

Joseph Roig

22 February 2022

Expert Insight

Considerations for use of hematopoietic stem cells in allogeneic therapies

Considerations for use of hematopoietic stem cells in allogeneic therapies

Barbara Seymour

Banking on the future of regenerative medicine with cGMP-compliant iPSC lines

Banking on the future of regenerative medicine with cGMP-compliant iPSC lines

Melissa K Carpenter

22 February 2022

Commentary

Regulatory & supply chain implications for plasmids as critical starting materials in the manufacture of viral vector gene therapy products

Regulatory & supply chain implications for plasmids as critical starting materials in the manufacture of viral vector gene therapy products

M Gosse, C Jones, D Jesus et al.

Challenges in qualification & management of raw materials in advanced therapy medicinal products

Challenges in qualification & management of raw materials in advanced therapy medicinal products

Shok Ping Lim, Sakina Gooljar

Interview

Adapting materials supply chain management for a post-pandemic world

Adapting materials supply chain management for a post-pandemic world

Dennis Royal

Troubleshooting quality assurance for AAV raw & starting materials

Troubleshooting quality assurance for AAV raw & starting materials

Biswaurp DasGupta

Standardization & analytical tool innovation in the cell & gene therapy field

Standardization & analytical tool innovation in the cell & gene therapy field

Fouad Atouf

Viewpoint

Pandemic-related supply chain disruptions in cell therapy require rapid qualification for single-sourced materials

Pandemic-related supply chain disruptions in cell therapy require rapid qualification for single-sourced materials

John Duguid, Paul Friedman

Webinars

Rapid translation of a cellular therapeutic: Choosing product & process development solutions for clinical manufacturing readiness

Rapid translation of a cellular therapeutic: Choosing product & process development solutions for clinical manufacturing readiness

Ashish Patel, Joseph Candiello