BioInsights - Vol 7 Issue 2

CELL & GENE THERAPY INSIGHTS

Vol 7 Issue 2

Cell & Gene Therapy 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
Other articles
Webinars

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

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

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, Mark Lowdell

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

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

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.

Commentary

Master ATMP processes by controlling raw and starting material

Master ATMP processes by controlling raw and starting material

Anne-Sophie Lebrun, Carmen Brenner

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

Interview

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

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.

Emerging trends in control and regulation of immunotherapy cellular starting materials

Emerging trends in control and regulation of immunotherapy cellular starting materials

Nate Manley

Sourcing and procurement best practices in the face of uncertainty

Sourcing and procurement best practices in the face of uncertainty

Richard Stout

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.

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

Interview

Update on new viral vector strategies in gene therapy

Update on new viral vector strategies in gene therapy

Clive Glover

25 February 2021

Update on the <em>Sleeping Beauty</em> 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

Journal articles

Innovator Insight

Breaking viral vector bioanalysis barriers with centrifugal force

Breaking viral vector bioanalysis barriers with centrifugal force

Patricia Ahrweiler

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 Prebil et al.

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

Commentary

2021: a key year for allogeneic cellular cancer immunotherapy?

2021: a key year for allogeneic cellular cancer immunotherapy?

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

Ramsey Shanbaky

Raw materials of biological origin: navigating regulatory requirements for cell therapies

Raw materials of biological origin: navigating regulatory requirements for cell therapies

Marlin Frechette, Dominic Clarke

13 January 2021

Focusing on donor characteristics and efficient selection to improve allogeneic cell therapy outcomes

Focusing on donor characteristics and efficient selection to improve allogeneic cell therapy outcomes

M MS, B PhD, D Gibson et al.

21 January 2021

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 PhD, L PhD, R Luke et al.

11 February 2021

Navigating current translational challenges in establishing clinical CAR T cell therapy manufacture

Navigating current translational challenges in establishing clinical CAR T cell therapy manufacture

D García Guerreiro, D Kassim, D Dudley et al.

Key considerations for hMSC product and process development through clinical cGMP manufacturing

Key considerations for hMSC product and process development through clinical cGMP manufacturing

J Rowley, R Barcia, J Candiello et al.