BioInsights - Vol 8 Issue 02

CELL & GENE THERAPY INSIGHTS

March 2022 Issue

Vol 8 Issue 02

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Featuring

Issue Spotlight: Raw and starting materials
Focus: Enhancing accuracy & throughput
Focus: Best practices for ensuring cell and gene therapy supply chain scalability
Other articles

SPOTLIGHT

Raw and starting materials
Gary du Moulin
Guest Editor:
Gary du Moulin, Consultant in Quality Systems and Compliance Strategies at Massachusetts College of Pharmacy & Health Sciences

Foreword

Raw & starting materials for cell and gene therapies

Raw & starting materials for cell and gene therapies

Gary du Moulin
11 March 2022
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Editorial

Managing variability in autologous apheresis collections

Managing variability in autologous apheresis collections

Joseph Roig
22 February 2022
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Expert Insight

Considerations for use of hematopoietic stem cells in allogeneic therapies

Considerations for use of hematopoietic stem cells in allogeneic therapies

Barbara Seymour
8 March 2022
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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
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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.
8 March 2022
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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
4 March 2022
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Interview

Adapting materials supply chain management for a post-pandemic world

Adapting materials supply chain management for a post-pandemic world

Dennis Royal
11 March 2022
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Troubleshooting quality assurance for AAV raw & starting materials

Troubleshooting quality assurance for AAV raw & starting materials

Biswaurp DasGupta
8 March 2022
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Standardization & analytical tool innovation in the cell & gene therapy field

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

Fouad Atouf
3 March 2022
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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
7 March 2022
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Analytics FOCUS

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

Susan Darling
16 March 2022
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Accelerating process development with at-line concentration measurement

Accelerating process development with at-line concentration measurement

Joe Ferraiolo
15 March 2022
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Interview

Analytical development insights spanning viral vectors & gene editing

Analytical development insights spanning viral vectors & gene editing

Santoshkumar Khatwani
11 March 2022
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Supply Chain FOCUS

Best practices for ensuring cell and gene therapy supply chain scalability

Journal articles

Innovator Insight

“This is not a sustainable model.”

“This is not a sustainable model.”

Joe DePinto, Robert Richards
21 February 2022
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Current technological trends & advancements in vector purification

Current technological trends & advancements in vector purification

Y Cai, N Clement, C Gaskin et al.
3 March 2022
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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.
21 March 2022
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Interview

Reflections on a life in gene therapy

Reflections on a life in gene therapy

Ronald G Crystal
28 February 2022
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Exploring the translational landscape of regenerative cell therapies

Exploring the translational landscape of regenerative cell therapies

Anthony Atala, MD
15 March 2022
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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

2 March 2022
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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

C Reardon, P Vermilion, J Yoshi Shyu
22 March 2022
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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.
27 March 2022
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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

C Reardon, P Vermilion, J Yoshi Shyu
22 March 2022
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