BioInsights - Raw and starting materials - spotlight

CELL & GENE THERAPY INSIGHTS

Raw and starting materials

Elizabeth Read

Guest Editor:

Elizabeth Read, Principal Consultant

March 2021

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

L Belcastro,

M Brabec,

L Clarke et al.

22 March 2021

Innovator Insight

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

A Hines

26 March 2021

Interview

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Raw and starting materials

E Read

26 March 2021

Foreword

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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

Interview

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

B Bonamassa,

P Gasparini,

G Pompilio et al.

25 March 2021

Regulatory Insight

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

A Michel,

D Neville

25 March 2021

Innovator Insight

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

B Weil,

M Lowdell

24 March 2021

Expert Insight

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Master ATMP processes by controlling raw and starting material

A Lebrun,

C Brenner

24 March 2021

Commentary

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Emerging trends in control and regulation of immunotherapy cellular starting materials

N Manley

19 March 2021

Interview

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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

G du Moulin

18 March 2021

Commentary

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Sourcing and procurement best practices in the face of uncertainty

R Stout

18 March 2021

Interview

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

S Zvonic

16 March 2021

Editorial

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

Jon Rowley, Founder and CPO, RoosterBio Inc.

Rita Barcia, Vice President of Research and Development, Sentien Biotech

Joe Candiello, Senior Product Manager, RoosterBio Inc.

Joseph Takacs, Field Application Scientist, RoosterBio Inc.

Jan Nolta, Professor, Director of the Stem Cell Program and Gene Therapy Center at University of California, Davis

Carolyn Yeago, Associate Director at Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech

Jim Birkhead, Director, Research & Development, Vericel Corporation

28 April 2021

Webinar

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

M Nelson

5 March 2021

Expert Insight

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

John Paul Tomtishen III, Director of Manufacturing, Technical Operations at Legend Biotech Co.

Lindsey Clarke, PhD , Global Product Marketing & Commercial Strategy, Cell & Gene Therapy, Bio-Techne

Lili Belcastro, PhD, Scientist, Biotherapeutics Material Sciences,Janssen Pharmaceutical R&D

Raymond Luke, Associate Director, MS&T, Adaptimmune

Mitchell Brabec, Commercial Development Specialist, Bio-techne

11 February 2021

Webinar

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

Martin Maiers, Vice President of Innovation, NMDP/Be The Match

Blake Aftab, PhD, Vice President, Preclinical & Translational Science, Atara Biotherapeutics, Inc.

Daniel Gibson, Director of Cell and Gene Therapy Services, Anthony Nolan

Joanne Kurtzberg, PhD, Director, Carolinas Cord Blood Bank, Duke University

Dorit Harati, Former Vice President, Quality Assurance, Manufacturing and Logistics, Gamida Cell

21 January 2021

Webinar

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

Marlin Frechette, Chief Quality & Compliance Officer, FUJIFilm Irvine Scientific

Dominic Clarke, Global Head of Cell Therapy, HemaCare Corporation

13 January 2021

Webinar

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