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

Tom Watson

 

Global Product Manager, Sterilizing- Grade Filters

Pall Biotech

Speakers

martha folmsbee

Martha Folmsbee PhD

 

Principal Scientist
Pall Corporation

aude iwaniec

Aude Iwaniec

 

R&D Engineer II
Pall Biotech

Biography

kelley mccabe

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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This webinar was recorded by BioPharma Asia and first published on their website. https://biopharma-asia.com. It is made available here by kind permission of BioPharma Asia and the presenters.

 

Hailed as the “next frontier” in cell therapy and regenerative medicine, exosomes are a type of extracellular vesicle and play a key role in the regulation of the intercellular communication processes.

David Haylock of VivaZome will present on upstream production of angiogenic exosomes using the iCELLis® nano fixed bed bioreactor. This will be followed by a presentation by Roberto Ciboldi of Pall Corporation on a platform solution including cell culture, purification and sterile filtration of exosomes.

Participants will be able to:

 

  • Compare the performance of the iCELLis Nano bioreactor to traditional flasks for exosome production from adherent cell culture
  • Understand how an integrated end to end platform delivers highly   purified and consistently-sized exosomes
  • Discover an innovative cGMP scalable manufacturing platform for   exosomes
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