Shinji Tsuji

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

Articles by Shinji Tsuji

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

Proposing a New Method of Detecting Pinholes in Single-Use

ByToshihiko Otsubo,Shinji Tsuji,Yoshiaki Miko,Tetsuya Moritake,Osamu Shirokizawa,Takashi Kaminagayoshi

September 1st 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

ByMakoto 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.

Latest Updated Articles

Proposing a New Method of Detecting Pinholes in Single-Use
September 1st 2020
Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals
September 1st 2018