Vol 7 Issue 2

CELL AND GENE THERAPY INSIGHTS

March 2021 Issue

Vol 7 Issue 2

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Featuring

Issue Spotlight: Raw and starting materials
New vectors – update on emerging viral & non-viral delivery platforms 2021
Other articles
Webinars

SPOTLIGHT

Raw and starting materials
Elizabeth Read
Guest Editor:
Elizabeth Read, Principal Consultant at EJ Read Consulting LLC

Foreword

Raw and starting materials

Raw and starting materials

Elizabeth Read
26 March 2021
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Editorial

Considerations for controlling the variability of raw biological materials in the manufacturing of autologous patient-specific therapies

Considerations for controlling the variability of raw biological materials in the manufacturing of autologous patient-specific therapies

Sanjin Zvonic
16 March 2021
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Expert Insight

The case for the use of pooled donors in the manufacture of allogeneic cell therapies

The case for the use of pooled donors in the manufacture of allogeneic cell therapies

Benjamin Weil
24 March 2021
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Upholding raw material suppliers to higher quality standards to better support cell and gene therapy manufacturers

Upholding raw material suppliers to higher quality standards to better support cell and gene therapy manufacturers

Monica C. Nelson, PhD
5 March 2021
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Innovator Insight

Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective

Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective

Alistair Michel, David Neville
25 March 2021
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Fitting product to process: raw materials customization for cell therapy manufacturing success

Fitting product to process: raw materials customization for cell therapy manufacturing success

L Belcastro, M Brabec, L Clarke et al.
22 March 2021
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Commentary

Master ATMP processes by controlling raw and starting material

Master ATMP processes by controlling raw and starting material

Anne-Sophie Lebrun, Carmen Brenner
24 March 2021
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Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Considerations for performing virtual quality audits on manufacturers of gene therapy viral vectors: an auditor’s perspective during the COVID-19 public health emergency

Gary C du Moulin, PhD, MPH, RAC
18 March 2021
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Interview

Managing raw and starting materials for viral vector manufacture: managing risk and staying flexible

Managing raw and starting materials for viral vector manufacture: managing risk and staying flexible

E Hacherl, C Klem, M Galbraith et al.
26 March 2021
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Expect the unexpected: maintaining and optimizing a cell collection network during COVID-19

Expect the unexpected: maintaining and optimizing a cell collection network during COVID-19

Amy Hines
26 March 2021
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Emerging trends in control and regulation of immunotherapy cellular starting materials

Emerging trends in control and regulation of immunotherapy cellular starting materials

Nate Manley
19 March 2021
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Sourcing and procurement best practices in the face of uncertainty

Sourcing and procurement best practices in the face of uncertainty

Richard Stout
18 March 2021
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Regulatory Insight

The importance of starting materials: quality and regulatory considerations for cell-based therapies

The importance of starting materials: quality and regulatory considerations for cell-based therapies

B Bonamassa, P Gasparini, G Pompilio et al.
25 March 2021
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Vectors FOCUS

New vectors – update on emerging viral & non-viral delivery platforms 2021

Interview

Update on new viral vector strategies in gene therapy

Update on new viral vector strategies in gene therapy

Clive Glover
25 February 2021
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Update on the Sleeping Beauty transposon system: current state-of-the-art & remaining challenges

Update on the Sleeping Beauty transposon system: current state-of-the-art & remaining challenges

Zoltán Ivics
18 February 2021
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Journal articles

Expert Insight

Top tips from industry leaders on optimizing your viral vector process intensification strategy

Top tips from industry leaders on optimizing your viral vector process intensification strategy

25 March 2021
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Innovator Insight

Exploring the capabilities of a versatile, novel, automated closed system for cell and gene therapy manufacturing

Exploring the capabilities of a versatile, novel, automated closed system for cell and gene therapy manufacturing

Sarah Daoudi, Premkumar Jayaraman
25 March 2021
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Breaking viral vector bioanalysis barriers with centrifugal force

Breaking viral vector bioanalysis barriers with centrifugal force

Patricia Ahrweiler
16 March 2021
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Multiple-parameter profiling of density gradient ultracentrifugation for characterization of empty and full capsid distribution in AAV preparations

Multiple-parameter profiling of density gradient ultracentrifugation for characterization of empty and full capsid distribution in AAV preparations

S Peljhan, M Štokelj, S Drmota Prebil et al.
16 March 2021
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Commentary

2021: a key year for allogeneic cellular cancer immunotherapy?

2021: a key year for allogeneic cellular cancer immunotherapy?

10 March 2021
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FastFacts

Streamlining at-line and in-line concentration measurements with the Variable Pathlength Technology approach

Streamlining at-line and in-line concentration measurements with the Variable Pathlength Technology approach

5 March 2021
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Webinars