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

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November 2020

From November 3rd to November 19th

 

There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale.

 

Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.

 

Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist.

 

There are flexible technologies that can meet each of the challenges during PD and at GMP scale.

 

Join this webinar series and learn more about securing process quality with flexible manufacturing solutions.

 

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  • Vaccines development, regulations and manufacturing Parts 1 & 2

 

  • Developing scalable upstream workflows for recombinant and viral vaccine processes

 

  • Downstream process development for vaccine manufacturing

 

  • Implementing single-use technologies in formulation and filling of vaccines
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