Sterile Filtration of Complex Liquids: Challenges & Optimization Using a Liposomal Model Fluid
Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint.
Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.
Participants will learn:
- The challenges of sterilizing liposome-based drugs prior to filling.
- A scalable method for producing liposomes with cGMP capability.
- Critical process parameters for sterilizing filtration of complex liposomal fluids.
- How to optimize sterile filtration of complex fluids and increase filter throughput using an example.
Global Product Manager, Sterilizing- Grade Filters
Martha Folmsbee PhD
R&D Engineer II
Senior Applications Engineer
Microfluidics International Corporation
Prepare for a Successful Validation of Liposome-Based Drugs
Download this guide to get recommendations for applying QbD principles for sterility assurance during aseptic processing
This talk will focus on an overall application of USP <665> starting from risk assessment to qualification of disposable manufacturing systems based on USP<665> data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP<665> data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.