Japanese pharmaceutical contract development and manufacturing organization Peptistar has integrated Asahi Kasei's forward osmosis–membrane distillation (FO–MD) system into its manufacturing facility for production-scale evaluation of active pharmaceutical ingredient (API) manufacturing.

According to Asahi Kasei, the system concentrates pharmaceutical solutions without applying heat or pressure, helping reduce the number of freeze-drying batches and the time required for freeze-drying. Peptistar has begun operating the system at manufacturing scale as part of its evaluation for Good Manufacturing Practice (GMP) production.

The FO–MD system is intended for manufacturing heat-sensitive APIs, including peptides and oligonucleotides, where conventional concentration methods can affect product quality. Forward osmosis removes water using osmotic pressure across a membrane, while membrane distillation removes volatile components such as acetonitrile, alcohol, and ammonia at or below room temperature.

According to Asahi Kasei, combining the two membrane technologies allows pharmaceutical manufacturers to produce highly concentrated solutions before freeze-drying while maintaining ingredient composition and reducing the risk of precipitation. The company says the approach can improve manufacturing productivity while supporting high purity and yield.

The system installed at Peptistar is designed for batches of up to 100 liters and is compatible with GMP-compliant operation. Asahi Kasei said the manufacturing-scale evaluation will help assess the technology's suitability for commercial pharmaceutical production as the company continues studying future commercialization opportunities.