From Lab to Plant: Predictable QbD for Spray-Dried ASDs

Predictable Scale-Up for Spray-Dried Amorphous Solid Dispersions

Scaling spray-dried amorphous solid dispersions (ASDs) from the laboratory to commercial manufacture can be challenging. Differences in equipment, process conditions and formulation behaviour can introduce risk, increase development timelines and lead to costly scale-up iterations. In this white paper, Codis explores how process simulation can enhance Quality by Design (QbD) for spray-dried ASD development. By linking critical material attributes (CMAs) and critical process parameters (CPPs) to key product quality outcomes, simulation enables a more scientific, data-driven approach to process development, technology transfer and commercial scale-up.   Discover how simulation-guided development can help teams:

• Improve confidence in spray-drying scale-up and technology transfer.
• Reduce experimental burden and minimise trial-and-error development.
• Establish scientifically justified operating ranges and design spaces.
• Better predict product quality attributes, including particle size distribution and residual solvent levels.
• Support robust manufacturing processes from early development through to commercial production