CELL & GENE THERAPY INSIGHTS

Spotlight

Raw and starting materials

Mar 2021
Guest Editor:
Elizabeth Read, Principal Consultant
Elizabeth Read
Principal Consultant

Foreword

Raw and starting materials

Elizabeth Read
26 March 2021
Foreword

Editorial


Expert Insight


Innovator Insight


Commentary


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

Vectors FOCUS

Report

Other articles

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

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

Webinars

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

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

Marlin Frechette
Marlin Frechette, Chief Quality & Compliance Officer, FUJIFilm Irvine Scientific
Dominic Clarke
Dominic Clarke, Global Head of Cell Therapy, HemaCare Corporation
13 January 2021
Webinar
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

Martin Maiers
Martin Maiers, Vice President of Innovation, NMDP/Be The Match
Blake Aftab, PhD
Blake Aftab, PhD, Vice President, Preclinical & Translational Science, Atara Biotherapeutics, Inc.
Daniel Gibson
Daniel Gibson, Director of Cell and Gene Therapy Services, Anthony Nolan
Joanne Kurtzberg, PhD
Joanne Kurtzberg, PhD, Director, Carolinas Cord Blood Bank, Duke University
Dorit Harati
Dorit Harati, Former Vice President, Quality Assurance, Manufacturing and Logistics, Gamida Cell
21 January 2021
Webinar
Fitting product to process: raw materials customization for cell therapy manufacturing success

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

John Paul Tomtishen III
John Paul Tomtishen III, Director of Manufacturing, Technical Operations at Legend Biotech Co.
Lindsey Clarke, PhD
Lindsey Clarke, PhD , Global Product Marketing & Commercial Strategy, Cell & Gene Therapy, Bio-Techne
Lili Belcastro, PhD
Lili Belcastro, PhD, Scientist, Biotherapeutics Material Sciences,Janssen Pharmaceutical R&D
Raymond Luke
Raymond Luke, Associate Director, MS&T, Adaptimmune
Mitchell Brabec
Mitchell Brabec, Commercial Development Specialist, Bio-techne
11 February 2021
Webinar
Navigating current translational challenges in establishing clinical CAR T cell therapy manufacture

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

Dr, Estefanía García Guerreiro
Dr, Estefanía García Guerreiro , Lead Researcher, Institute of Biomedicine of Seville (IBIS)
Dr. Sadik Kassim
Dr. Sadik Kassim, CTO, Vor BioPharma
Dr. Mark Dudley
Dr. Mark Dudley, Senior Vice President Early Development, Adaptimmune
Dr. Anthony Welch
Dr. Anthony Welch, Program Officer/Program Director Biological Resources Branch, National Cancer Institute
7 April 2021
Webinar
Key considerations for hMSC product and process development through clinical cGMP manufacturing

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

Jon Rowley
Jon Rowley, Founder and CPO, RoosterBio Inc.
Rita Barcia
Rita Barcia, Vice President of Research and Development, Sentien Biotech
Joe Candiello
Joe Candiello, Senior Product Manager, RoosterBio Inc.
Joseph Takacs
Joseph Takacs, Field Application Scientist, RoosterBio Inc.
Jan Nolta
Jan Nolta, Professor, Director of the Stem Cell Program and Gene Therapy Center at University of California, Davis
Carolyn Yeago
Carolyn Yeago, Associate Director at Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech
Jim Birkhead
Jim Birkhead, Director, Research & Development, Vericel Corporation
28 April 2021
Webinar