Cell and Gene Therapy Insights Volume 8 Issue 2

CELL AND GENE THERAPY INSIGHTS

Volume 8 Issue 2

Cell and Gene Therapy Insights Volume 8 Issue 2

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Featuring

Issue Spotlight: Raw and starting materials
Analytics focus: Enhancing accuracy & throughput
Other articles
Webinar

Raw and starting materials

Gary du Moulin

Guest Editor:

Gary du Moulin, Consultant in Quality Systems and Compliance Strategies at Fairlead Quality

Foreword

Raw & starting materials for cell and gene therapies

Raw & starting materials for cell and gene therapies

Editorial

Managing variability in autologous apheresis collections

Managing variability in autologous apheresis collections

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

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

Interview

Adapting materials supply chain management for a post-pandemic world

Adapting materials supply chain management for a post-pandemic world

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

Enhancing accuracy & throughput

Innovator Insight

Accelerating AAV capsid analysis using a new multi-capillary electrophoresis platform

Accelerating AAV capsid analysis using a new multi-capillary electrophoresis platform

Accelerating process development with at-line concentration measurement

Accelerating process development with at-line concentration measurement

Interview

Analytical development insights spanning viral vectors & gene editing

Analytical development insights spanning viral vectors & gene editing

Santoshkumar Khatwani

articles

Review

Purification of therapeutic & prophylactic mRNA by affinity chromatography

Purification of therapeutic & prophylactic mRNA by affinity chromatography

J Grinsted, J Liddell, E Bouleghlimat et al.

Innovator Insight

The EuLV® System, an inducible stable producer cell line for lentiviral vector production

The EuLV® System, an inducible stable producer cell line for lentiviral vector production

B Xue, N Yang, A Liu et al.

Current technological trends & advancements in vector purification

Current technological trends & advancements in vector purification

Y Cai, N Clement, C Gaskin et al.

“This is not a sustainable model.”

“This is not a sustainable model.”

Joe DePinto, Robert Richards

21 February 2022

Expert Roundtable

Strategies for scaling up and out in gene therapy manufacturing: addressing AAV’s growing pains

Strategies for scaling up and out in gene therapy manufacturing: addressing AAV’s growing pains

Christopher Reardon, Phillip Vermilion, John Yoshi Shyu

Poster

Roundtable Roundup: strategies for scaling up and out in gene therapy manufacturing - addressing AAV’s growing pains

Roundtable Roundup: strategies for scaling up and out in gene therapy manufacturing - addressing AAV’s growing pains

Christopher Reardon, Phillip Vermilion, John Yoshi Shyu

Podcast

Key factors to consider for successful cell therapy manufacturing: a case study

Key factors to consider for successful cell therapy manufacturing: a case study

Interview

Exploring the translational landscape of regenerative cell therapies

Exploring the translational landscape of regenerative cell therapies

Anthony Atala, MD

Reflections on a life in gene therapy

Reflections on a life in gene therapy

Ronald G Crystal

28 February 2022

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