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

CELL AND GENE THERAPY INSIGHTS

March 2020

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

Foreword

Raw and Starting Materials – Foreword

Raw and Starting Materials – Foreword

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

AS Prakasha Gowda, Andrew Schaefer, Terry 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

David L DiGiusto, Rakib Ouro-Djobo, Uzair 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 St. 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

Kasey Kime, Jerrod Denham, Christopher Bravery

Ensuring source material consistency & continuity for commercialization of advanced therapies

Ensuring source material consistency & continuity for commercialization of advanced therapies

Dominic Clarke, Christopher Good, Amy 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

Raw material qualification and optimization: the Janssen approach

Raw material qualification and optimization: the Janssen approach

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

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

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

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

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

Kasey Kime, Jerrod Denham, Christopher Bravery

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

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

David DiGiusto, Bernd Leistler, Tom Walls

Expert Roundtable

Overcoming raw material challenges in cell & gene therapy manufacturing

Overcoming raw material challenges in cell & gene therapy manufacturing

David DiGiusto, Bernd Leistler, Tom 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

Kasey Kime, Jerrod Denham, Christopher 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.