Vol 6 Issue 2

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

Foreword

Raw and Starting Materials – Foreword

Steven Goodman

8 April 2020

Foreword

Assessing and managing raw material risk

Tom Walls

1 April 2020

Editorial

A simple RP-HPLC method for the stability-indicating determination of <em>N</em>-acetyl-L-cysteine and <em>N,N’</em>-diacetyl-L-cystine in cell culture media

A simple RP-HPLC method for the stability-indicating determination of N-acetyl-L-cysteine and N,N’-diacetyl-L-cystine in cell culture media

AS Prakasha Gowda,

Andrew Schaefer,

Terry Schuck

8 April 2020

Research Article

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

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

The role of raw materials in the manufacturing of cell and gene therapy medicinal products: practices and challenges

José Caraballo

9 April 2020

Commentary

Meeting the evolving challenges of media supply to the cell and gene therapy space

Jason C Lin

20 April 2020

Interview

Raw material qualification and optimization: the Janssen approach

Lili Belcastro

9 April 2020

Interview

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture

Hélène Pora

9 April 2020

Interview

Optimizing and standardizing apheresis: critical next steps for the cell therapy industry

Joseph M Roig

1 April 2020

Interview

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture – Podcast

Hélène Pora

4 May 2020

Podcast

Listen now

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

Watch now

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

David DiGiusto,

Bernd Leistler,

Tom Walls

13 April 2020

Expert Roundtable Video

Watch now

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto,

Bernd Leistler,

Tom Walls

27 April 2020

Expert Roundtable

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

Kasey Kime,

Jerrod Denham,

Christopher Bravery

27 April 2020

Regulatory Insight

Global cell and gene therapy supply chain strategies at commercial scale

Expert Insight

Supply chain challenges and issues facing the autologous cell manufacturing industry

Kan Wang,

Ben Wang,

Chelsea White,

Aaron D Levine

23 April 2020

Expert Insight

Best practice for raw materials management on a global basis

Stephane Lameynardie

24 April 2020

Interview

Enabling clinical development of cell and gene therapies on a global basis

20 April 2020

Interview

Enabling clinical development of cell and gene therapies on a global basis - Podcast

Brandon Fletcher,

Tamie Joeckel,

Martin Lachs,

Olivier Saulin

20 April 2020

Podcast

Listen now

Report

Innovation Insights March 2020

Expert Insight

Durable and curative responses in heart disease: promises and practicalities

Gabor Foldes,

Vasiliki E Kalodimou

17 March 2020

Expert Insight

ATMP innovation in liver disease

Anil Dhawan

25 March 2020

Interview

Current and future directions for dendritic cell vaccines

Gerard Bos

23 March 2020

Interview

Regulatory Insights March 2020

Editorial

Curing ultra-rare diseases while ensuring access, equity and affordability

R Jude Samulski,

Laura Hameed

19 March 2020

Editorial

Innovator Insight

Webinars

Ensuring source material consistency and continuity for commercialization of advanced therapies

Dominic Clarke, Global Head of Cell Therapy, HemaCare Corporation

Amy Shaw, Lead, Cell Therapies Engineering & Automation Development at Takeda Pharmaceutical Company Limited

Christopher Good, Director, Cell & Gene Therapy Logistics at Biocair International Limited

12 March 2020

Webinar

Watch now

Enabling new cell therapies with GMP-compliant multiparametric cell sorting

Steve Elliman, CSO at Orbsen Therapeutics Ltd

Ivy Lai, Lab Manager at MD Anderson Cancer Center

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, Consultant at Miltenyi Biotec

Felix Eppler, PhD, Group Leader, Cell Sorting Product Management, Miltenyi Biotec

18 March 2020

Webinar

Watch now

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

Chris McClain, Head of Business Development & Sales at Be The Match BioTherapies

Marty Giedlin, Senior Vice President, Process Development at PACT Pharma, Inc.

Behnam Baghbaderani, Global Head, Process Development, Emerging Technologies at Lonza Pharma & Biotech

Philippe Parone, Industrialization Director at Celyad SA

7 May 2020

Webinar

Watch now

CELL & GENE THERAPY INSIGHTS

Mar 2020. Vol 6 Issue 2

FEATURING

Spotlight

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

Sponsors

Co-sponsors

Foreword

Raw and Starting Materials – Foreword

Editorial

Assessing and managing raw material risk

Research Article

A simple RP-HPLC method for the stability-indicating determination of N-acetyl-L-cysteine and N,N’-diacetyl-L-cystine in cell culture media

Expert Insight

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

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

Innovator Insight

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

Ensuring source material consistency & continuity for commercialization of advanced therapies

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

Commentary

The role of raw materials in the manufacturing of cell and gene therapy medicinal products: practices and challenges

Interview

Meeting the evolving challenges of media supply to the cell and gene therapy space

Raw material qualification and optimization: the Janssen approach

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture

Optimizing and standardizing apheresis: critical next steps for the cell therapy industry

Podcast

Maximizing speed to market: flexibility benefits of single-use technology for gene therapy manufacture – Podcast

Expert Roundtable Video

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

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

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

Regulatory Insight

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

Supply Chain FOCUS

Global cell and gene therapy supply chain strategies at commercial scale

Expert Insight

Supply chain challenges and issues facing the autologous cell manufacturing industry

Interview

Best practice for raw materials management on a global basis

Enabling clinical development of cell and gene therapies on a global basis

Podcast

Enabling clinical development of cell and gene therapies on a global basis - Podcast

Report

Innovation Insights March 2020

Expert Insight

Durable and curative responses in heart disease: promises and practicalities

Interview

ATMP innovation in liver disease

Current and future directions for dendritic cell vaccines

Report

Regulatory Insights March 2020

Editorial

Curing ultra-rare diseases while ensuring access, equity and affordability

Other articles

Innovator Insight

Webinars

Ensuring source material consistency and continuity for commercialization of advanced therapies

Enabling new cell therapies with GMP-compliant multiparametric cell sorting

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