Science & Research

Continuous Manufacturing of Liposomal Drug Formulations

Performer: University of Connecticut

Principal Investigator: Diane J. Burgess, Ph.D.

Project Duration: 9/30/13 - 9/29/16

Regulatory Science Challenge

The use of novel science and technologies is leading both to innovations in manufacturing and to innovative products that are often complex. To foster these innovations and ensure that product quality standards are being maintained, FDA is collaborating with academia and industry to assess how new manufacturing technologies may be affecting product safety, efficacy, and quality. The resulting information is critical to inform FDA as it develops regulatory policy relevant to these innovations. This project is intended to investigate the effects of continuous manufacturing (as opposed to batch manufacturing) on product quality.

Project Description

The School of Pharmacy at the University of Connecticut is developing an automated, continuous process for manufacturing liposomal drug formulations. Currently, the manufacturing of liposomes involves only batch processing. A continuous manufacturing process, including the use of quality-by-design (QbD) experiments will enable critical manufacturing parameters to be adjusted during manufacturing to reduce failure rates and produce consistent, higher quality liposomal products. The proposed continuous manufacturing method will be designed such that a base platform will be developed that can be easily modified for specific applications and that is applicable to all liposomal formulations.

Project Goals

  • Develop continuous manufacturing and assessment methods for liposomes.

  • Implement the QbD approach to determine the limitations of the continuous processing method.

  • Introduce PAT to the continuous manufacturing process to perform in-line monitoring of liposome formulations at various stages.

  • Modify the system as needed to create a smart continuous manufacturing system – such that the system will adjust necessary parameters to maintain product quality.

Achievements

  • Developed continuous liposome formation stage.
  • Began writing a computer program to support an automated process control.
  • Performed QbD experiments and determined key processing factors that influenced liposome particle size and size distribution.
  • Determined that liposomal particle size and size distribution can be precisely controlled.
  • Implemented a purification/concentration stage to remove ethanol and concentrate the liposomes.

Page Last Updated: 05/17/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English