Vol 5 Issue 2

CELL AND GENE THERAPY INSIGHTS

Vol 5 Issue 2

Cell and Gene Therapy Insights Vol 5 Issue 2

Featuring

Issue Spotlight: Raw and Starting Materials
Purification 2019
Other articles
Webinars

Raw and Starting Materials

Foreword

Raw and Starting Materials – Foreword

Raw and Starting Materials – Foreword

Robert G Piperno

Research Article

Genomic-QC: large-scale genomic data mining to assess the quality of HiPSC lines

Genomic-QC: large-scale genomic data mining to assess the quality of HiPSC lines

R More, M Rao, O Mukherjee

Expert Insight

Raw materials in cell therapy: start right early in process development

Raw materials in cell therapy: start right early in process development

Anna Gilbert

Can iPSCs Address the Challenge of Maintaining Consistent Quality in Starting Materials Used in the Manufacture of Cell-Based Therapies?

Can iPSCs Address the Challenge of Maintaining Consistent Quality in Starting Materials Used in the Manufacture of Cell-Based Therapies?

Kilian Kelly

Qualification of cellular starting materials for cell-based therapies

Qualification of cellular starting materials for cell-based therapies

Elizabeth Read

Perspective

How to effectively manage critical raw materials to support clinical development in CAR-T cell therapy

How to effectively manage critical raw materials to support clinical development in CAR-T cell therapy

E Gauthy, L Lambricht, S Snykers

Innovator Insight

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

Dominic Clarke, David Smith

Interview

Making an efficient & effective transition to GMP raw materials

Making an efficient & effective transition to GMP raw materials

Udo Nirenberg

Raw and starting material considerations for gamma delta T cell therapy

Raw and starting material considerations for gamma delta T cell therapy

Stewart Abbot

Identifying Critical Quality Attributes of cellular starting materials

Identifying Critical Quality Attributes of cellular starting materials

Dr. Krishnendu Roy

Staying ahead of the game: understanding and managing patient-to-patient variability

Staying ahead of the game: understanding and managing patient-to-patient variability

Jan Melenhorst

Podcast

Making an efficient & effective transition to GMP raw materials

Making an efficient & effective transition to GMP raw materials

Udo Nirenberg

Expert Roundtable Video

Expert Roundtable: Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

Expert Roundtable: Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

R McFarland, I Kljavin, T Moore

Expert Roundtable

Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

R McFarland, I Kljavin, T Moore

Purification 2019

Podcast

Room for improvement: tackling suboptimal downstream process unit operations for viral vectors

Room for improvement: tackling suboptimal downstream process unit operations for viral vectors

D Marshall, P Smith, C Glover

Interview

Addressing challenges presented for downstream purification by changes upstream

Addressing challenges presented for downstream purification by changes upstream

Marian Bendik

A question of balance: the value of an integrated approach to AAV US and DS bioprocessing

A question of balance: the value of an integrated approach to AAV US and DS bioprocessing

Tarik Senussi

Room for improvement: tackling suboptimal downstream process unit operations for viral vectors

Room for improvement: tackling suboptimal downstream process unit operations for viral vectors

D Marshall, P Smith, C Glover

Journal articles

Commercial Insights

Cell & Gene Therapy Commercial Insight – February 2019

Cell & Gene Therapy Commercial Insight – February 2019

Mark Curtis, Richard Philipson

Addressing the challenges of preserving cell and gene therapies

Addressing the challenges of preserving cell and gene therapies

Q Rafiq, A Schlinker, D Maier

18 January 2019

Made-for-purpose manufacturing solutions - The key to commercialization

Made-for-purpose manufacturing solutions - The key to commercialization

N Bauer, B Dutra, S Leslie

31 January 2019

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

Dominic Clarke, David Smith

21 February 2019

Designing GMP-friendly cell and gene therapy manufacturing processes

Designing GMP-friendly cell and gene therapy manufacturing processes

M Papadimitrious, X Wang, B Murphy

Critical components for developing and managing expansive, high-performing collection networks

Critical components for developing and managing expansive, high-performing collection networks

A Hines, R Smith, J Vitale et al.

Planning for success: emerging GMP-grade raw materials & technologies for cell therapy

Planning for success: emerging GMP-grade raw materials & technologies for cell therapy

S Kevlahan PhD, L Fox, Á Herrero Méndez PhD et al.