OR WAIT null SECS
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.
Submitted: Jan. 9, 2020
Accepted: June 3, 2020
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.
Vol. 33, No. 9
When referring to this article, please cite is as F. Mirasol, “Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging,” BioPharm International 33 (9) 2020.