Continuous Virus Filtration: Solutions for Virus Challenge Testing and Production Sterility

 

‌Advances in enabling technology such as multi-column chromatography and single pass tangential flow filtration have empowered the production of monoclonal antibody (mAb) products and other biologics through continuous processing and process intensification.  This has led to the increase in scenarios where adjacent unit operations need to operate at lower process flowrates for greatly extended processing times.
 
Two major practical difficulties arise out of this new design space of extended processing time for virus filtration: simple sterility assurance, and the ability to generate effective virus challenge data over long periods of time.  Both are increased in complexity by the use of adsorptive prefiltration and virus filtration in the same system.
 
We demonstrate the effective performance of a gamma irradiated prefilter and virus filter pairing in one single use system for effective mAb processing and sterility assurance.  We also present three different approaches to generating virus challenge data with extended mAb processes and adsorptive prefilters: one spike, one study; spike replenishment; and in-line spiking.  All techniques can deliver stable and consistent input spikes over 4 days, with the latter two methods capable of being extended to any desired process time and a variety of virus and product stability scenarios.  Batch and continuous scenarios are compared with either 4 hour or 4 day processing of high mAb throughput (1600 L/m2, 12 kg/m2) and > 6 log retention of minute virus of mice.

Speaker

Nigel Jackson

 

‌Principal Engineer R&D

Pall Biotech

Since his PhD in Biochemical Engineering, Nigel Jackson has over 10 years of experience in Biotech Process R&D within Pall Biotech.  Nigel has multiple publications and conference presentations demonstrating a deep understanding of virus filtration and general bioprocessing.  He has directed this knowledge into helping Pall develop robust and effective new virus filters and many other Pall Biotech products and applications.  He has also recently taken on the role of Visiting Lecturer at University College London.

Biography

Continuous Virus Filtration: Solutions for Virus Challenge Testing and Production Sterility

Discover how to design your virus filter validation study

Download this application note to learn how to design your validation study for your virus filter

  • How much virus spike you should load and the influence it has on flow decay
  • How to incorporate a prefilter into your study

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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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