BioInsights - Raw and starting materials: troubleshooting supply, management and optimisation issues - spotlight

CELL & GENE THERAPY INSIGHTS

Steven Goodman

Guest Editor:

Steven Goodman, Senior Director, Drug Product Manufacturing at bluebird bio, Inc

March 2020

Co-sponsor

Co-sponsor

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

Foreword

Raw and Starting Materials – Foreword

Raw and Starting Materials – Foreword

Steven Goodman

Editorial

Assessing and managing raw material risk

Assessing and managing raw material risk

Research Article

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

A Gowda, A Schaefer, T Schuck

Expert Insight

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

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

D DiGiusto, R Ouro-Djobo, U Rajput

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

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

A Mack, T Matthews, B Germain et al.

Innovator Insight

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

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

K Kime, J Denham, C Bravery

Ensuring source material consistency & continuity for commercialization of advanced therapies

Ensuring source material consistency & continuity for commercialization of advanced therapies

D Clarke, C Good, A Shaw

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

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

A Klarer, H Steidinger, A Taylor et al.

Commentary

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

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

José Caraballo

Interview

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

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

Jason C Lin

Raw material qualification and optimization: the Janssen approach

Raw material qualification and optimization: the Janssen approach

Lili Belcastro

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

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

Hélène Pora

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

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

Joseph M Roig

Podcast

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

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

Hélène Pora

Expert Roundtable Video

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

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

K Kime, J Denham, C Bravery

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

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

D DiGiusto, B Leistler, T Walls

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

Overcoming raw material challenges in cell & gene therapy manufacturing

D DiGiusto, B Leistler, T Walls

Regulatory Insight

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

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

K Kime, J Denham, C Bravery

Webinars

Ensuring source material consistency and continuity for commercialization of advanced therapies

Ensuring source material consistency and continuity for commercialization of advanced therapies

D Clarke, A Shaw, C Good

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

C McClain, M Giedlin, B Baghbaderani et al.