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What is Aseptic Process Simulation in Gene Therapy about?

This document discusses considerations for aseptic process simulation (APS), also known as media fills, for cell and gene therapy processes. It covers regulatory guidance, APS challenges, facility readiness, risk assessment, media selection, operator qualification, and identifying worst-case parameters. APS is intended to challenge the aseptic portion of the process under worst-case conditions to confirm that the process can produce aseptically processed products, but should not include intentionally disrup

Author

JumpLin

Language

EN