Manufacturing and Bioprocessing
2019 PharmSci 360
Self-assembled polymeric micelles (PMs) due to their small size and unique in vivo targeting characteristics make them an ideal delivery system for therapeutic treatment involving anti-cancer and anti-inflammatory agents. Although these products have high potential to overcome unmet therapeutic needs, ensuring manufacturing consistency to produce high quality and cost-effective complex drug products can be challenging, in part attributed to the complex nature of the manufacturing processes and a lack of understanding of key properties such as drug-polymer interactions, processing controls, etc. Hence, in recent years, continuous processing (CP) is gaining acceptance due to improved process control leading to faster production, reduced manufacturing cost and greatly improve product quality. The current work focused on outlining key material attributes and process parameters associated with CP and development of a CP platform for PMs using an innovative co-axial jet in co-flow technology and a specific example of paclitaxel loaded PMs will be presented.