Category: Manufacturing and Bioprocessing
Purpose: There has been growing interest in the area of complex drug products (such as polymeric micelles (PMs), liposomes, and microspheres) over the past few decades. Especially, self-assembled polymeric nanoparticles are finding a wide range of applications in the delivery of hydrophobic drug substances. 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. It is estimated that the pharmaceutical manufacturing industry wastes up to $50 billion per year on inefficient processes1. In recent years, to overcome potential batch-to-batch variation typically observed using traditional batch manufacturing processes, continuous processing is gaining acceptance as it has been shown to achieve improved process control (via process analytical technology)2, 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 continuous processing of PMs that potentially affect their critical quality attributes. Accordingly, we have developed a continuous processing platform for PMs using an innovative co-axial jet in co-flow technology and a specific example of paclitaxel-loaded PMs will be presented.
Antonio Costa– Assistant Research Professor, University of Connecticut, Storrs Mansfield, Connecticut
Su-Lin Lee– Science Staff, USFDA, Silver Spring, Maryland
Celia Cruz– Division Director, FDA/CDER/OPQ/OTR/DPQR, Silver Spring, Maryland
Xiaoming Xu– Senior Staff Fellow, U. S. Food and Drug Administration, Silver Spring, Maryland
Diane Burgess– Distinguished Professor of Pharmaceutics, University of Connecticut, Storrs Mansfield, Connecticut