- Aenova has introduced a new hot melt extrusion (HME) platform at its Regensburg site to support bioavailability enhancement for poorly soluble drugs.
- The technology is capable of processing highly potent compounds up to OEB 5 and supports seamless scale-up to GMP production.
Aenova has expanded its advanced technology offering with the introduction of a hot melt extrusion (HME) platform at its Regensburg, Germany site. The platform enables the production of amorphous solid dispersions (ASDs) for active pharmaceutical ingredients (APIs) up to Occupational Exposure Band (OEB) 5.
The addition is designed to address a critical challenge in pharmaceutical development: improving the oral bioavailability of poorly soluble drug candidates. Aenova reports that approximately 80% of preclinical compounds face solubility and absorption issues, which can hinder clinical progression. The new twin-screw extrusion technology is intended to enhance solubility by converting APIs from a crystalline to an amorphous state, thereby improving dissolution rates.
The Regensburg site features advanced infrastructure for handling highly potent compounds (OEL < 1 µg/m³), along with full in-house analytical and API characterisation capabilities. The HME platform, supplied by Leistritz, supports scale-up from lab development to GMP production, aligning with Quality-by-Design (QbD) principles.
“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.
