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- 60 Minutes
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
Tom joined Pall in 2003, having graduated from the University of Sheffield with a degree in Biotechnology and Microbiology. Following several years as an Account Manager, in 2010 he joined the Global Product Marketing team to take up his current position as Global Product Manager, Sterilizing-Grade Filters. Working closely alongside Pall R&D, Tom’s key focus is the development and introduction of a range of sterilizing-grade filter products designed for use in biopharmaceutical manufacturing.
Martha Folmsbee PhD
Martha specializes in bacterial and bacteriophage retention testing of sterilizing grade filters. Her work includes a special focus on mycoplasma clearance and sterile filtration of complex fluids. Martha received a Masters in Environmental Science from the University of Oklahoma in 1997 and later her PhD in Microbiology in 2004.
R&D Engineer II
Aude joined the Pall Biotech Process R&D team in 2016. She is based in the UK and specialises in sterilising grade filtration. During her time at Pall, she has gained experience in the filtration of various molecules and complex fluids including high concentration mAbs and liposomes. Aude graduated from the Swiss Federal Institute of Technology in Lausanne (EPFL) with a Masters in Chemical Engineering.
Senior Applications Engineer
Microfluidics International Corporation
Kelley is a senior applications engineer at Microfluidics. She has a background in chemical engineering and physics from Syracuse University. She has vast experience processing various applications with Microfluidics technology processors performing proof of concept, process optimization and scale up testing for customers.
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