This presentation has been recorded during BPI EUROPE Digital Week 2021.
When a developed virus filtration process is validated by viral clearance testing, the addition of a virus spike for just this purpose can lead to disappointing results. Not achieving processing targets like throughput or viral clearance targets such as log reduction can cause development delay and cost increases. Problems can be produced by the virus spike itself, product stability, clearance testing methods, and complications due to prefilter implementation. Process development and viral clearance laboratories have to communicate in significant detail to ensure successful clearance testing that suitably mimics the final production process. We give some guidance and examples of what can be done to mitigate the occurrence of unsatisfactory results and get to the maximum achievable outcome during a viral clearance study for a batch process with prefiltration. We also take a brief look at how the findings and recommendations could be translated to a continuous process setting.
Nigel Jackson, Principal Engineer R&D
Principal Engineer R&D
Since his PhD in Biochemical Engineering, Nigel Jackson has over 10 years of experience in Biotech Process R&D within Pall. 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 products and applications. He has also recently taken on the role of Visiting Lecturer at University College London.
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