- Toray's new membrane module offers four times the filtration performance in one-fifth the volume.
- Full-scale sales begin in April 2026 for processes meeting Good Manufacturing Practice standards.
- Funding was partially provided by Japan Agency for Medical Research and Development grants.
- The module will be showcased at nano tech 2026 in Tokyo from January 28-30, 2026.
Introduction
Toray Industries has launched a high-efficiency separation membrane module designed for biopharmaceutical purification processes. This new module significantly enhances filtration performance while reducing space and buffer solution usage.
Market Context
The biopharmaceutical market is rapidly growing due to advancements in gene therapy drugs and next-generation antibodies. However, high manufacturing costs remain a challenge, necessitating cost reduction and stable supply structures.
Technical Challenges
Gene therapy drug manufacturing faces issues with impurities and clogged purification membranes, leading to increased pressures and insufficient purification levels. These challenges reduce equipment utilization rates and cause drug recovery losses.
Module Features
The new module combines a pretreatment membrane with a hollow fiber ultrafiltration membrane, minimizing clogging and pressure rises while increasing filtrate flows. This is achieved through optimized pore structure and antifouling technology.
Testing and Standards
Testing by the Manufacturing Technology Association of Biologics confirmed the module's ability to purify pharmaceuticals without quality or recovery rate issues. Toray plans to start full-scale sales in April 2026, targeting processes that meet Good Manufacturing Practice standards.
Funding and Future Plans
The development was partially funded by grants from the Japan Agency for Medical Research and Development. Toray will exhibit the module at nano tech 2026 in Tokyo and aims to expand its membrane area lineup to meet pharmaceutical manufacturers' demands.
