AbbVie supports the development and commercialization of Hot Melt Extrusion and amorphous solid dispersions (ASD) consists of 6 stages:
Assess technical feasibility for ASD formulation & HME process by evaluating small quantities of API.
Develop prototypes and clinical formulations.
Clinical manufacturing in Lake County, IL or Germany.
Define final dosage form & commercial process train, CMPs & CPPs.
Scale up and optimize process at commercial scale and define design space.
Commercial manufacturing in Germany or Puerto Rico.
10+ Extruders in Network
- 18 mm – 70 mm screw size
- Multiple OEMs (Liestritz, Coperion, Bosch)
- Potent capability (<1 μg/m3)
- Continuous melt granulation
- Sites in US and Europe
- Barceloneta, Puerto Rico
- Ludwigshaven, Germany
Downstream Manufacturing Options
- Controlled Release
- Modified Release