BioInsights - Vol 5 Issue 6

CELL & GENE THERAPY INSIGHTS

Vol 5 Issue 6

Cell & Gene Therapy Vol 5 Issue 6

Featuring

Issue Spotlight: Global Regulatory Update
Focus: Data Management & Integration
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

O Ball, S Robinson, C 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

F Nappi, F Capone, M 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

Jaeseung Lim

US FDA goals and priorities for cell & gene therapy regulation

US FDA goals and priorities for cell & gene therapy regulation

Peter Marks

Update on the regulatory environment for ATMPs in Israel

Update on the regulatory environment for ATMPs in Israel

Ofra Axelrod

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

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

D Patel, J Lefton, H 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

Jordan Croteau

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.

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

NextGen now - Delivering tomorrow’s facilities today

NextGen now - Delivering tomorrow’s facilities today

Marc Pelletier, Ryan McDonough