Aenova has now introduced a new hot melt extrusion platform at its Regensburg site.
This twin-screw extrusion platform is ready to be used in producing amorphous solid dispersions (ASD) for APIs up to OEB 5.
Unlocking the full potential of drug candidates
Approximately 80% of preclinical drug candidates face bioavailability limitations due to poor aqueous solubility and slow absorption in the gastrointestinal tract. These issues can delay clinical development and hinder the delivery of life-changing therapies to patients. Aenova’s science-driven formulation strategies, including hot melt extrusion and spray drying for amorphous solid dispersions (ASDs), are designed to overcome these barriers efficiently and effectively.
Hot melt extrusion: a key technology for bioavailability enhancement
Hot melt extrusion (HME) is one of the most effective and versatile technologies for improving the bioavailability of poorly soluble compounds. The process transforms the crystalline structure of the API into an amorphous solid dispersion, significantly enhancing its solubility and dissolution rate.
At Aenova’s Regensburg site, the new HME platform equipped with cutting-edge technology from manufacturer Leistritz enables seamless scale-up from lab-scale development to full GMP production. This ensures speed, consistency, and cost-efficiency across the product lifecycle.
A centre of excellence for high-potency formulations
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 characterisation and analytical capabilities. With decades of experience in formulation science, polymer selection, process optimisation, and Quality-by-Design product development, Aenova delivers customised, firsttime-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.
