CELL & GENE THERAPY INSIGHTS

Spotlight

Raw and starting materials: troubleshooting supply, management and optimisation issues

Mar 2020
Guest Editor:
Steven Goodman, Senior Director, Drug Product Manufacturing at bluebird bio, Inc
Steven Goodman
Senior Director, Drug Product Manufacturing at bluebird bio, Inc

Foreword

Raw and Starting Materials – Foreword

Steven Goodman
8 April 2020
Foreword

Editorial


Research Article


Expert Insight

Developing and implementing a supply chain management system for cellular therapy programs

David L DiGiusto,
Rakib Ouro-Djobo,
Uzair Rajput
9 April 2020
Expert Insight

Considerations on impact of raw material variability in gene therapy manufacturing: applying lessons learned from biologics manufacturing

Aaron Mack,
Thomas Matthews,
Bryan St. Germain,
John Kerwin,
David Kolwyck,
Greg Stromberg
8 April 2020
Expert Insight

Innovator Insight

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials - ANIMATION

Kasey Kime,
Jerrod Denham,
Christopher Bravery
6 October 2020
Innovator Insight

Ensuring source material consistency & continuity for commercialization of advanced therapies

Dominic Clarke,
Christopher Good,
Amy Shaw
27 April 2020
Innovator Insight

Improving the quality cell yield of T-cell immunotherapies through selective pressures imparted by culture media supplements

Alex Klarer,
Hayley Steidinger,
Amanda Taylor,
Steven Charlebois,
David Smith,
Steven Thompson
8 April 2020
Innovator Insight

Commentary


Interview


Podcast


Expert Roundtable Video

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials – on demand webinar

Kasey Kime,
Jerrod Denham,
Christopher Bravery
27 April 2020
Expert Roundtable Video

Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto,
Bernd Leistler,
Tom Walls
13 April 2020
Expert Roundtable Video

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto,
Bernd Leistler,
Tom Walls
27 April 2020
Expert Roundtable

Regulatory Insight

Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials

Kasey Kime,
Jerrod Denham,
Christopher Bravery
27 April 2020
Regulatory Insight

Supply Chain FOCUS

Report

Expert Insight

Durable and curative responses in heart disease: promises and practicalities

Gabor Foldes,
Vasiliki E Kalodimou
17 March 2020
Expert Insight

Interview

ATMP innovation in liver disease

Anil Dhawan
25 March 2020
Interview

Report

Other articles

Innovator Insight

Webinars

Ensuring source material consistency and continuity for commercialization of advanced therapies

Ensuring source material consistency and continuity for commercialization of advanced therapies

Dominic Clarke
Dominic Clarke, Global Head of Cell Therapy, HemaCare Corporation
Amy Shaw
Amy Shaw, Lead, Cell Therapies Engineering & Automation Development at Takeda Pharmaceutical Company Limited
Christopher Good
Christopher Good, Director, Cell & Gene Therapy Logistics at Biocair International Limited
12 March 2020
Webinar
Enabling new cell therapies with GMP-compliant multiparametric cell sorting

Enabling new cell therapies with GMP-compliant multiparametric cell sorting

Steve Elliman
Steve Elliman, CSO at Orbsen Therapeutics Ltd
Ivy Lai
Ivy Lai, Lab Manager at MD Anderson Cancer Center
Dr Sandy Pelletier
Dr Sandy Pelletier, Scientific Coordinator, Adoptive Cell Transfer (ACT) Immunotherapy Program, Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CRCHUM)
Jack Dunne
Jack Dunne, Consultant at Miltenyi Biotec
Felix Eppler, PhD
Felix Eppler, PhD, Group Leader, Cell Sorting Product Management, Miltenyi Biotec
18 March 2020
Webinar
From vein to vein: how starting material quality impacts the manufacturing and success of next-generation therapies

From vein to vein: how starting material quality impacts the manufacturing and success of next-generation therapies

Chris McClain
Chris McClain, Head of Business Development & Sales at Be The Match BioTherapies
Marty Giedlin
Marty Giedlin, Senior Vice President, Process Development at PACT Pharma, Inc.
Behnam Baghbaderani
Behnam Baghbaderani, Global Head, Process Development, Emerging Technologies at Lonza Pharma & Biotech
Philippe Parone
Philippe Parone, Industrialization Director at Celyad SA
7 May 2020
Webinar