Shinji Tsuji

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Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Articles

Nikolai Sorokin/Stock.adobe.com - concept illustrating a needle that can cause pinholes

Proposing a New Method of Detecting Pinholes in Single-Use

Toshihiko Otsubo;Shinji Tsuji;Yoshiaki Miko;Tetsuya Moritake;Osamu Shirokizawa;Takashi Kaminagayoshi
September 2nd 2020

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

Makoto Sadamitsu;Shunsuke Omori;Tetsuya Ohta;Shinji Tsuji
September 1st 2018

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.

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