Asahi Kasei installs novel FO-MD system at Peptistar to speed up API manufacturing

JAPAN – Japanese pharmaceutical contract development and manufacturing organization (CDMO) Peptistar has installed Asahi Kasei’s forward osmosis–membrane distillation (FO–MD) system at its manufacturing facility to support the trial production of active pharmaceutical ingredients (APIs).

The technology is designed to shorten manufacturing time by concentrating pharmaceutical solutions without heat or pressure, enabling manufacturers to produce sensitive APIs more efficiently.

The system has now entered manufacturing-scale evaluation as Peptistar prepares for Good Manufacturing Practice (GMP) production.

New technology targets faster API production

Asahi Kasei first unveiled the FO–MD technology in 2018 as an alternative to conventional concentration methods that rely on heat or pressure.

Instead, the system removes water and volatile solvents under mild conditions, preserving the quality of heat-sensitive pharmaceutical ingredients while reducing the workload during freeze-drying.

By concentrating the solution before freeze-drying, manufacturers can process fewer batches and complete production in less time.

Peptistar has now begun operating the system at manufacturing scale using batches of up to 100 litres as it evaluates the technology for GMP-compliant production.

The installation comes as pharmaceutical manufacturers increasingly seek more efficient ways to produce complex therapies while maintaining high product quality and improving manufacturing productivity.

Addressing the challenges of next-generation medicines

The pharmaceutical industry has gradually shifted away from producing mainly high-volume small-molecule drugs toward more advanced products such as peptides, biologics, oligonucleotides and viral vectors.

Many of these newer therapies are highly sensitive to heat, making conventional concentration methods less suitable.

Traditionally, manufacturers have relied on freeze-drying to remove solvents without damaging delicate ingredients.

Although effective, freeze-drying consumes significant time and energy.

Existing concentration technologies, including vacuum distillation, may also expose products to heat or alter solvent composition, increasing the risk of degradation or unwanted precipitation.

Asahi Kasei’s FO–MD system overcomes these limitations by combining two membrane-based processes.

Forward osmosis removes water through natural osmotic pressure, allowing highly concentrated API solutions to form under gentle conditions.

Membrane distillation then removes volatile solvents such as acetonitrile, alcohol and ammonia at or below room temperature.

Unlike conventional tangential flow filtration, which can experience membrane fouling or leakage when processing highly concentrated solutions, the FO–MD approach maintains concentration efficiency while helping preserve ingredient quality.

The combined process also enables manufacturers to prepare highly concentrated solutions for freeze-drying without altering ingredient composition or causing precipitation.

Supporting Asahi Kasei’s life science strategy

The new installation forms part of Asahi Kasei’s broader strategy to strengthen its life science business through innovative manufacturing technologies.

The company continues to expand its research and development portfolio across healthcare and advanced materials, including recent investments in antibody-drug conjugate technologies and other life science innovations.

By introducing the FO–MD system into Peptistar’s manufacturing operations, Asahi Kasei aims to demonstrate that the technology can deliver high-purity, high-yield API production while reducing manufacturing time and energy consumption.

The company will continue evaluating the system’s commercial potential as GMP-scale testing progresses.