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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.
The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
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