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Troubleshooting process and analytical tool changes in an approved ATMP process

Year: 2024
Type: article
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®.
Authors: Maitane Ortiz, Marta Malo De Molina
Language: English
Subfield: Physiology
Field: Medicine
Open Access status: hybrid
OpenAlex ID: W7115588939
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