Toray Industries has developed a high-efficiency separation membrane module for biopharmaceutical manufacturing processes. This module delivers more than double the filtration performance of conventional counterparts by reducing clogging. It should also lift biopharmaceutical yields to more than 90% and enhance purification.

The company will initially supply prototypes to diverse customers to evaluate in purification processes for producing gene therapy drugs with a view to swift commercialization.

Recent years have seen the pharmaceutical market shift from conventional small-molecule drugs to biopharmaceuticals. Gene therapies and other treatment modalities are also coming to market in what seems to be an ongoing trend. A prime downside is the high manufacturing costs for these biopharmaceuticals, which are driving up medical expenses.

Gene therapy drugs are made with cultured cells. Purification entails using a depth filter to remove cell fragments from the culture medium, after which an ultrafiltration membrane removes impurities like proteins. Depth filter clogging or gene therapy drug adhesion to the ultrafiltration membrane can cause active ingredient losses, leading to higher costs.

Toray’s new separation membrane module comprises a depth filter incorporating multiple types of non-woven fabric and a hollow fiber ultrafiltration membrane.

The company tapped technologies it amassed in innovating air filter products to develop the depth filter. Optimizing the fiber thickness and void structure of the nonwoven fabric has enhanced filtration, improving gene therapy permeability and impurity removal.

In creating its ultrafiltration membrane, Toray employed hollow fiber membranes incorporating anti-fouling, surface-hydrophilization technology that it developed through its work on artificial kidneys (note 6). This advance prevents substances from adhering to the membrane, resisting protein adsorption and reducing clogging.

Toray will establish a mass production system and looks to launch sales during the fiscal year ending in March 2026.