Troubleshooting process and analytical tool changes in an approved ATMP process

With the continuing rapid pace of process and analytical tools innovation in the cell and gene therapy field, manufacturers of approved products must embrace improved new technologies while ensuring their regulatory requirements are fulfilled. David McCall (Senior Editor, BioInsights) talks to Takeda’s Maitane Ortiz Virumbrales (Associate Director) and Marta Malo de Molina (Process Engineer Lead) about key considerations and success factors gleaned from their experiences with Alofisel®.

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Publication Details

Journal
Cell and Gene Therapy Insights
Published
2024-12-03
DOI
https://doi.org/10.18609/cgti.2024.176
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
0.00
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article

Troubleshooting process and analytical tool changes in an approved ATMP process

Cell and Gene Therapy Insights
CAR-T cell therapy research
article

Troubleshooting process and analytical tool changes in an approved ATMP process

article en

Abstract

With the continuing rapid pace of process and analytical tools innovation in the cell and gene therapy field, manufacturers of approved products must embrace improved new technologies while ensuring their regulatory requirements are fulfilled. David McCall (Senior Editor, BioInsights) talks to Takeda’s Maitane Ortiz Virumbrales (Associate Director) and Marta Malo de Molina (Process Engineer Lead) about key considerations and success factors gleaned from their experiences with Alofisel®.

Cell and Gene Therapy InsightsVol. 10(10)
Takeda (United States) (US), MeaningCloud (Spain) (ES)
Industry, innovation and infrastructure
Openalex Percentile: Top 43%
CAR-T cell therapy research
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Troubleshooting process and analytical tool changes in an approved ATMP process · Cell and Gene Therapy Insights (2024) | TGRS Research Map | TGRS