Vol 7 Issue 2

Raw and starting materials

Mar 2021

Guest Editor:

Elizabeth Read, Principal Consultant

Foreword

Raw and starting materials

Elizabeth Read

26 March 2021

Foreword

Editorial

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

Sanjin Zvonic

16 March 2021

Editorial

Expert Insight

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

Benjamin Weil,

Mark Lowdell

24 March 2021

Expert Insight

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

Monica C. Nelson, PhD

5 March 2021

Expert Insight

Innovator Insight

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

Innovator Insight

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

Lili Belcastro,

Mitchell Brabec,

Lindsey Clarke,

Raymond Luke,

John Paul Tomtishen III

22 March 2021

Innovator Insight

Commentary

Master ATMP processes by controlling raw and starting material

Anne-Sophie Lebrun,

Carmen Brenner

24 March 2021

Commentary

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

Commentary

Interview

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

Amy Hines

26 March 2021

Interview

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

Eric Hacherl,

Christopher Klem,

Mark Galbraith,

Ryan Bartock

26 March 2021

Interview

Emerging trends in control and regulation of immunotherapy cellular starting materials

Nate Manley

19 March 2021

Interview

Sourcing and procurement best practices in the face of uncertainty

Richard Stout

18 March 2021

Interview

Regulatory Insight

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

Barbara Bonamassa,

Paolo Gasparini,

Giulio Pompilio,

Alessandro Aiuti,

Paolo Foggi

25 March 2021

Regulatory Insight

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

Interview

Update on new viral vector strategies in gene therapy

Clive Glover

25 February 2021

Interview

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

Interview

Clinical Trends February 2021

Commentary

2021: a key year for allogeneic cellular cancer immunotherapy?

Sven Kili

10 March 2021

Commentary

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

Michael Delahaye,

Michael DiBiasio-White,

Franz Gerner,

Jessica Tate,

Jim Warren, Ph.D,

Susan D’Costa

25 March 2021

Innovator Insight

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

Sarah Daoudi,

Premkumar Jayaraman

25 March 2021

Innovator Insight

Breaking viral vector bioanalysis barriers with centrifugal force

Patricia Ahrweiler

16 March 2021

Innovator Insight

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

Sebastijan Peljhan,

Maja Štokelj,

Sara Drmota Prebil,

Pete Gagnon,

Aleš Štrancar

16 March 2021

Innovator Insight

FastFacts

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

Ramsey Shanbaky

5 March 2021

FastFacts

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

Watch now

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

Watch now

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

Watch now

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

Dr, Estefanía García Guerreiro , Lead Researcher, Institute of Biomedicine of Seville (IBIS)

Dr. Sadik Kassim, CTO, Vor BioPharma

Dr. Mark Dudley, Senior Vice President Early Development, Adaptimmune

Dr. Anthony Welch, Program Officer/Program Director Biological Resources Branch, National Cancer Institute

7 April 2021

Webinar

Watch now

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

Watch now

CELL & GENE THERAPY INSIGHTS

Mar 2021. Vol 7 Issue 2

FEATURING

Spotlight

Raw and starting materials

Sponsors

Co-sponsor

Foreword

Raw and starting materials

Editorial

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

Expert Insight

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

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

Innovator Insight

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

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

Commentary

Master ATMP processes by controlling raw and starting material

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

Interview

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

Emerging trends in control and regulation of immunotherapy cellular starting materials

Sourcing and procurement best practices in the face of uncertainty

Regulatory Insight

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

Vectors FOCUS

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

Interview

Update on new viral vector strategies in gene therapy

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

Report

Clinical Trends February 2021

Commentary

2021: a key year for allogeneic cellular cancer immunotherapy?

Other articles

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

Innovator Insight

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

Breaking viral vector bioanalysis barriers with centrifugal force

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

FastFacts

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

Webinars

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

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

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

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

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