Manufacturing and Bioprocessing
2019 PharmSci 360
Approximately 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. Polymorphism, purity and crystal size distribution are key control objectives of pharmaceutical crystallization processes, directly impacting the drug quality including solubility and rheological behavior during downstream processing.
Recently, there have been efforts from the pharmaceutical industry to transition from batch to continuous unit operations. Although setup costs for batch methods are typically lower (due to existing equipment), these methods are inefficient and are estimated to represent up to $50 billion in losses to the industry annually. Supercritical CO2-antisolvent crystallization has attracted interest due to its potential to control the crystalline form of APIs as well as generate particles on the nano-scale.
This talk will discuss the major benefits and obstacles represented by continuous manufacturing of pharmaceutical nanoparticles using supercritical techniques, which represent novel approaches to manufacture large and small molecule products.