Japanese pharmaceutical contract development and manufacturing organization (CDMO) Peptistar has integrated Asahi Kasei’s innovative forward osmosis–membrane distillation (FO–MD) system into its active pharmaceutical ingredient (API) manufacturing facility. The company has begun operating the system at manufacturing scale as part of its evaluation for Good Manufacturing Practice (GMP) production.
Asahi Kasei first announced the development of the FO–MD system in 2018. The technology dehydrates and concentrates liquids without applying heat or pressure, significantly reducing the number of freeze-drying batches and shortening overall API manufacturing time.
Growing Demand for Advanced API Manufacturing
The pharmaceutical industry has witnessed a major shift in API demand, moving beyond traditional high-volume small molecules to biologics, peptides, oligonucleotides, viral vectors, and other next-generation therapeutics. As these APIs become increasingly complex and highly specific, manufacturers require advanced production technologies that can preserve product quality while improving efficiency.
Many next-generation APIs, particularly peptides and oligonucleotides, are highly sensitive to heat. Consequently, manufacturers have relied on freeze-drying to remove solvents without exposing these compounds to high temperatures. However, freeze-drying remains a costly, energy-intensive, and time-consuming process.
Although manufacturers can shorten freeze-drying by concentrating raw material solutions beforehand, conventional concentration technologies such as vacuum distillation expose materials to heat, increasing the risk of quality degradation. In addition, changes in solvent composition during concentration may lead to unwanted precipitation.
FO–MD Technology Overcomes Manufacturing Challenges
Asahi Kasei’s FO–MD system addresses these limitations by concentrating pharmaceutical raw material solutions without using heat or pressure. The forward osmosis (FO) process removes water through an osmotic pressure difference across a membrane, enabling highly concentrated API solutions under mild operating conditions.
Unlike the tangential flow filtration (TFF) process commonly used in API manufacturing, FO maintains concentration efficiency even at higher API concentrations, where fouling and leaks can affect recovery rates.
Meanwhile, the membrane distillation (MD) process removes volatile components such as acetonitrile, alcohol, and ammonia by utilizing a vapor pressure difference across a membrane at or below room temperature.
As per the press release, combining FO and MD technologies enables manufacturers to prepare highly concentrated solutions for freeze-drying while maintaining ingredient composition and preventing precipitation.
Improved Productivity and GMP Readiness
The integrated FO–MD system significantly reduces freeze-drying time, enabling manufacturers to produce APIs with high purity, high yield, and improved productivity. The system installed at Peptistar’s manufacturing facility can process batches of up to 100 liters and has been designed to support GMP-compliant operations.
Peptistar is currently operating the system at manufacturing scale as part of its evaluation for future GMP production.
Supporting Future Commercialization
Looking ahead, Asahi Kasei plans to further evaluate the commercialization potential of its FO–MD technology. The initiative aligns with the company’s broader structural transformation strategy, which identifies Life Science as a key Growth Potential business under its medium-term management plan.
