Asahi Kasei FO–MD system installed at Peptistar for API manufacturing trials
- Asahi Kasei’s forward osmosis–membrane distillation (FO–MD) system has been installed at Peptistar for trial production of APIs.
- The FO–MD process concentrates liquids without heat or pressure using osmotic and vapor pressure differences, building on development announced in 2018.
- The system is designed for batches up to 100 L and to be compatible with GMP-compliant operation during evaluation.
- FO–MD aims to reduce freeze-drying batches and shorten freeze-drying time while avoiding precipitation and quality degradation seen with heated concentration methods.
Installation and purpose
Asahi Kasei’s forward osmosis–membrane distillation (FO–MD) system has been installed at Peptistar’s peptide and oligonucleotide API manufacturing facility for manufacturing-scale trials as part of an evaluation toward GMP production.
Technology background
The FO–MD concept, first announced by Asahi Kasei in 2018, combines forward osmosis (FO) and membrane distillation (MD) to remove water and volatile solvents without applying heat or pressure. FO uses an osmotic pressure difference across a membrane to concentrate solutions under mild conditions; MD uses a vapor pressure difference to remove volatile components at or below room temperature.
Manufacturing benefits
By concentrating heat-sensitive APIs without heating, the FO–MD system reduces the liquid volume fed to freeze-drying, cutting the number of freeze-drying batches and total freeze-dry time. The combined process maintains ingredient composition and avoids precipitation and quality degradation risks associated with heated concentration methods and with tangential flow filtration at high concentrations.
Scale and next steps
The installed unit is compatible with batches up to 100 L and designed for GMP operation during evaluation. Asahi Kasei is studying prospects for commercialization and positioning the technology within its Life Science growth strategy.
Source: Asahi Kasei