Process Optimization Strategies for Virus Filtration of Human Plasma Derived Products
Sponsored by: Sartorius Stedim Biotech
- Virus Filtration
- Orthogonal Virus Clearance
Date: 6 June
Days to go: 18
Time: 3PM London/10AM New York
Fouling behaviour, effect of adsorptive pre-filtration and dilution on overall performance and process robustness
Virus filtration is a widely used method for the removal of enveloped and non-enveloped viruses in the manufacturing of plasma derived products. Virus filters with pore sizes of 20 nm are available from different suppliers and are able to efficiently and reliably remove small viruses including parvoviruses which have resistance to physicochemical treatment. Therefore, virus filtration is an essential part of the orthogonal virus clearance strategy for immunoglobulins and blood coagulation factors that are not too large. Yet, the selection of the most suitable virus filter for a given set of process conditions depends on a combination of factors of which throughput (with or without a pre-filter) and associated feed stream variability are the most investigated ones during first and second round screening. The throughput of virus filters is in essence determined by the rate and extent of membrane fouling or in other words its resistance to fouling which can be understood as ‘fouling robustness’.
This webinar sheds a new light on how the principles of action of different adsorptive pre-filter matrices (hydrophobic interaction and cation exchange) and the pre-filter to virus filter ratio influence the binding of highly fouling species of hydrophobic and hydrophilic nature and eventually the throughput which in turn contributes to the overall process economics. Possible strategies to counteract fouling of the final virus filter are discussed such as the implementation of an adsorptive pre-filter, the dilution of the feedstream or the implementation of changes in the feed stream such as pH & conductivity.
For instance, dilution of the feed stream can influence molecule folding as well as protein-protein interaction and can therefore have a positive impact on product throughput performance of the virus filter.
Once the most optimal conditions and filter matrices are chosen, it is required that a virus clearance reduction (LRV) of > 4 is reached regardless what critical process parameters were chosen. During the 2nd part of this webinar, the ‘virus retention robustness’ is demonstrated of a new generation surface modified PESU virus filter for varying flow decay, operating pressure, pressure release, virus load, pH and conductivities. All data shown are based on IvIG buffered solutions which are representative for real applications.
The last and final part of the webinar focusses on validation strategies and good operational practices for surface modified PESU based virus filters. More specifically, the strategy for a virus clearance study for a scenario with and without adsorptive pre-filter is discussed as well as good practices for integrity testing.
Please register now to reserve your spot for this exciting webinar and we look forward to welcoming you to our presentation.
Product Manager Virus Clearance, Sartorius Stedim Biotech
Anika Manzke joined Sartorius in 2004 as an application specialist for Purification Technologies. During this time she was involved in downstream development activities of multiple processes within Europe. Later she transferred to the US market and was working there for 2 years within a similar position. There she already focused on virus clearance technologies as she is a biologist from education with expertise in virology. She worked on retroviral vectors for gene therapy before joining Sartorius. After returning from the United States in October 2009, she took over the global responsibility of Product Management for Virus Clearance within the Separation Group.
Geert Lissens, PhD,
Head of Segment Marketing Blood and Plasma, Sartorius Stedim Biotech
Geert Lissens joined Sartorius Stedim Biotech in September 2016 as a Field Marketing Manager Filtration Technologies and since September 2018 he is leading the plasma market segment to address specific needs and define future strategies. Geert has over 13 years of experience in the biotechnology industry and specializes in downstream processing and single use technologies in various markets and applications. Geert began his career at Millipore where he gained broad experience in technical functions as well as sales and key account management. Then he joined JSR Life Sciences to develop the European market for their protein A affinity business and to grow the membrane chromatography business of Natrix Separations.
Geert oversees the Sartorius’ technologies & products used in plasma manufacturing in close collaboration with Sartorius’ Product Management and technical experts to address the user needs in this strongly growing segment.
Key Learning Objectives
- Fouling mechanisms and its relation to throughput for virus filters made of different matrices
- What process optimization strategies can be used to increase filter fouling robustness.
- Proof of evidence that critical process parameters do not influence viral retention for surface modified PESU virus filters from Sartorius Stedim Biotech
- Validation strategies and good practices for integrity testing of virus filters and adsorptive pre-filters
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors