Fachvortrag
Ein neuer Weg zum aseptischen ATMP Produktion
A new concept for aseptic manufacturing of ATMPs
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ATMP manufacturing is a delicate process, requiring aseptic manufacturing throughout operations. Such process is mostly operated in a cleanroom B environment, with a mix of open steps and closed devices. Tech transfer of such processes can be a long process, which often requires adaptations from original manufacturing protocols. Which platform helps us eliminate the risks associated with tech transfer to clinical manufacturing? What do we need to keep in mind, to take the leap of faith to GMP production? What is the GMP state of mind and how does it impact the way we plan processes and develop solutions? What define a holistic and compliant manufacturing platform?
Referent*innen:
Michela Castellani-Kleinschroth