Proposing a New Method of Detecting Pinholes in Single-Use

September 2, 2020
Toshihiko Otsubo

Toshihiko Otsubo is principal scientist of Biologics Process Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

,
Shinji Tsuji

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

,
Yoshiaki Miko

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

,
Tetsuya Moritake

Tetsuya Moritake is associate director of Project Leadership & Operations, Pharmaceutical Sciences at Takeda Pharmaceutical.

,
Osamu Shirokizawa

Osamu Shirokizawa is president of Life Scientia.

,
Takashi Kaminagayoshi

Takashi Kaminagayoshi is director and head of Manufacturing Operations of Biogics Process Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

BioPharm International, BioPharm International-09-01-2020, Volume 33, Issue 9
Page Number: 35–39

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

In recent years, there has been increasing use of single-use bags in a broad range of fields, with remarkable advances in the development and manufacture of biopharmaceuticals, vaccines, and other medical products. On the other hand, single-use bags are at risk of pinholes and other defects during manufacturing processes, and there is currently no practical equipment that enables product testing to be performed conveniently and quickly. Given this situation, the authors have developed a new method of pinhole detection for single-use bags.

A composite film comprising two conductive layers is used as the primary material and may be checked easily for damage or pinholes in terms of insulation by applying a voltage directly on the film before and after use of the bag. Characterized by the idea that the bag constitutes part of the testing system, this method involves changing only the material, without changing the current bag design (shape, size) or attachments, such as nozzles. Various advantages are thus offered, and it is believed to be highly practical. In this paper, the authors report the principle of this method and the results of some investigations, with mention of future prospects.

Peer-Reviewed

Submitted: Jan. 9, 2020
Accepted: June 3, 2020

About the authors

Toshihiko Otsubo* is principal scientist of Biologics Process Development; Shinji Tsuji is associate director of Biologics Process Development; Yoshiaki Miko is associate director of Biologics Process Development; Tetsuya Moritake is associate director of Project Leadership & Operations; and Takashi Kaminagayoshi is director and head of Manufacturing Operations of Biogics Process Development; all with Pharmaceutical Sciences at Takeda Pharmaceutical. Osamu Shirokizawa is president of Life Scientia.

*To whom correspondence should be addressed.

Article Details

BioPharm International
Vol. 33, No. 9
September 2020
Pages: 35–39

Citation

When referring to this article, please cite is as F. Mirasol, “Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging,” BioPharm International 33 (9) 2020.

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