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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