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

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.

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

icon image

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

.

더 Biotech Webinars
Our webinars keep you informed on the latest products and technologies, current industry topics, the latest trends and a range of innovations and solutions to help continuously improve your processes.
March 2021
Case Study: Swissfillon’s Approach to Single-Use Formulation & Filling

Biotech | Pall Corporation 웨비나 시리즈

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
시청