Aenova has added a new hot melt extrusion platform for producing amorphous solid dispersions (ASD) for APIs up to OEB 5. The new HME platform is equipped with cutting-edge technology from manufacturer Leistritz and enables seamless scale-up from lab-scale development to full GMP production. This ensures speed, consistency, and cost-efficiency across the product lifecycle. The Regensburg site is fully equipped to handle highly potent compounds up to OEB 5 (OEL < 1 μg/m³) and features comprehensive in-house API characterization and analytical capabilities. With decades of experience in formulation science, polymer selection, process optimization, and Quality-by-Design product development, Aenova delivers customized, first-time-right solutions that unlock the full therapeutic potential of complex drug candidates.
“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,” says Florent Bordet, Chief Scientific Officer at Aenova.