Cell and Gene Therapy Insights Volume 5 Issue 6

CELL AND GENE THERAPY INSIGHTS

Volume 5 Issue 6

Cell and Gene Therapy Insights Volume 5 Issue 6

Featuring

Issue Spotlight: Global Regulatory Update
Supply Chain focus: Data Management & Integration 2019
Other articles
Webinars

Global Regulatory Update

Christiane Niederlaender

Guest Editor:

Christiane Niederlaender, Vice President Technical at Parexel

Editorial

European developments in ATMP Regulation

European developments in ATMP Regulation

Christiane Niederlaender

Perspective

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

Oliver Ball, Sarah Robinson, Christopher Bravery

Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Neil WA McGowan, John DM Campbell

Gene therapy success: how to keep its promises and improve – a regulatory perspective

Gene therapy success: how to keep its promises and improve – a regulatory perspective

Filomena Nappi, Francesca Capone, Maria Cristina Galli

The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

A Kuta, E Sawyer, M Cantor et al.

Interview

Korea’s evolving regulatory landscape for cell & gene therapies

Korea’s evolving regulatory landscape for cell & gene therapies

US FDA goals and priorities for cell & gene therapy regulation

US FDA goals and priorities for cell & gene therapy regulation

Update on the regulatory environment for ATMPs in Israel

Update on the regulatory environment for ATMPs in Israel

Regulatory Insight

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Y Maruyama, M Kasai, Y Fujiwara et al.

Data Management & Integration 2019

Interview

Supply chain data management and integration: process development and manufacturing

Supply chain data management and integration: process development and manufacturing

From the get-go: how to ensure your organization is built with harnessing data in mind

From the get-go: how to ensure your organization is built with harnessing data in mind

Darshan Patel, Jarrod Lefton, Hubert Sun

Keys to successful supply chain data management for T-cell immunotherapy

Keys to successful supply chain data management for T-cell immunotherapy

Charles Wilfong, Dan Lowther

Journal articles

Expert Roundtable Video

AAV vector process development: achieving high purity & high yield – experiences from the frontline

AAV vector process development: achieving high purity & high yield – experiences from the frontline

M Bakhshayeshi, M Mercaldi, M Hebben et al.

Expert Roundtable

AAV vector process development: achieving high purity and high yield – experiences from the frontline

AAV vector process development: achieving high purity and high yield – experiences from the frontline

M Bakhshayeshi, M Mercaldi, M Hebben et al.

Interview

Optimizing cell-based product consistency through automation

Optimizing cell-based product consistency through automation

Nadine Mockel-Tenbrinck

2 November 2019

Maximising data standardisation and reproducability from flow cytometry

Maximising data standardisation and reproducability from flow cytometry

30 September 2019

Progress and challenges in the development of bi-specific CAR-T cell therapies

Progress and challenges in the development of bi-specific CAR-T cell therapies

Bryon Johnson, Nirav Shah

15 September 2019

Enabling the next level of pluripotent stem-cell based therapies, from bench to commercialization

Enabling the next level of pluripotent stem-cell based therapies, from bench to commercialization

Puspa Pandey, Fan Yang

Implementation of biopreservation best practices to address a critical component of cell and gene therapy manufacturing

Implementation of biopreservation best practices to address a critical component of cell and gene therapy manufacturing

Alireza Abazari MSc PhD

NextGen now - Delivering tomorrow’s facilities today

NextGen now - Delivering tomorrow’s facilities today

Marc Pelletier, Ryan McDonough