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

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

2020-06-01T15:35:00.000Z
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March 2021

In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
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