Aenova, a leading CDMO, has launched a hot melt extrusion (HME) platform at its Regensburg, Germany facility, enhancing its capabilities to improve the bioavailability of poorly soluble pharmaceutical ingredients. The twin-screw extrusion system, supplied by Leistritz, supports the production of amorphous solid dispersions (ASDs) for active pharmaceutical ingredients (APIs) up to OEB 5 potency levels, addressing a critical need in drug development.

Approximately 80% of preclinical drug candidates suffer from poor solubility, slowing absorption and delaying clinical progress. Aenova’s HME technology transforms crystalline APIs into amorphous forms, boosting solubility and dissolution rates. The Regensburg site’s new platform enables seamless scaling from lab to full GMP production, ensuring efficiency and consistency. The facility also offers advanced API characterization and analytical services, reinforcing its role as a hub for high-potency formulations.

“With our new hot melt extrusion technology, Aenova is expanding its range of innovative platforms to provide modern, end-to-end solutions for our customers’ poorly soluble molecules, from pre-formulation and development to commercial manufacturing,” said Florent Bordet, Chief Scientific Officer at Aenova.

The company’s expertise in formulation science and Quality-by-Design development complements the HME system, enabling customized solutions for complex drugs.

Aenova’s investment reflects growing industry demand for innovative technologies to unlock the potential of difficult-to-formulate compounds, positioning the firm to meet the needs of pharmaceutical companies racing to bring new therapies to market.