Vol 5 Issue 6

CELL AND GENE THERAPY INSIGHTS

Vol 5 Issue 6

Cell and Gene Therapy Insights Vol 5 Issue 6

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Featuring

Issue Spotlight: Global Regulatory Update
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

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

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

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

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

Supply chain data management and integration: process development and manufacturing

Supply chain data management and integration: process development and manufacturing

Journal articles

Interview

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

Optimizing cell-based product consistency through automation

Optimizing cell-based product consistency through automation

Nadine Mockel-Tenbrinck

2 November 2019

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.

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