Abstract
AbstractIn this case study, a biotech drug product manufacturing site located in Bari/Italy was looking to develop a single‐use system integrity test at the point of use. The aim was to support the implementation of single‐use technology for filling of an innovative immune‐oncologic drug using a state‐of the‐art manufacturing isolator line. This publication describes the method development and validation of a process‐specific single‐use system integrity test considering both the technical challenges of testing the integrity of a single‐use system as well as the integrity assurance requirements in a good manufacturing practice environment.
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