Sterile Filtration of Complex Liquids: Challenges & Optimization Using a Liposomal Model Fluid

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:

 

  1. The challenges of sterilizing liposome-based drugs prior to filling.
  2. A scalable method for producing liposomes with cGMP capability.
  3. Critical process parameters for sterilizing filtration of complex liposomal fluids.
  4. How to optimize sterile filtration of complex fluids and increase filter throughput using an example.

Moderator

Tom Watson

 

Global Product Manager, Sterilizing- Grade Filters

Pall Biotech

Speakers

Martha Folmsbee PhD

 

Principal Scientist
Pall Corporation

Aude Iwaniec

 

R&D Engineer II
Pall Biotech

Biography

Kelley McCabe

 

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

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April 2022
Getting Ready for SUT X-Ray Irradiation

Biotech | Pall Corporation webinar series

Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare

 

The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.

 

Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.

 

You will learn more about:

 

  • Why this is a critical change for industry and the responsibilities of each stakeholder
  • Key questions to address for biomanufacturers
  • How gamma and X-ray irradiation compare
  • What testing has been completed and key milestones for readiness for industry
  • An example of how to qualify a SUS sterilized with X-ray irradiation
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