- Development of a continuous manufacturing platform for liposomal products
- Incorporation of PAT for critical quality attributes and process controls
- Precise control over particle size and insurance of monodisperse particles
- Adaptation to other nanoparticulates
This presentation will focus on the development of a continuous manufacturing platform for complex parenterals. Liposomes as well as polymeric micelles, and lipid nanoparticles will be discussed. Key aspects in the development of these novel therapeutics will be addressed together with insights into critical issues in the manufacturing process. Our laboratory has developed a novel continuous manufacturing platform for complex parenteral dosage forms which allows precise control over particle size and can also ensure monodisperse particles. This platform is equipped with process analytical technology to ensure all aspects of product quality. An overview of this manufacturing platform will be presented. The platform is based on co-flow technology and employs the formation of a turbulent jet at the site where the two flows mix, promoting vesicle formation. Case studies on different therapeutics prepared using this technology will be discussed.
Diane J. Burgess, Ph.D., Board of Trustees Distinguished Professor of Pharmaceutics Pfizer Distinguished Chair of Pharmaceutical Technology , University of Connecticut