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