When it comes to establishing a viral clearance process, ensuring patient safety is a top priority. To ensure this, regulators require that manufacturing processes have a validated cGMP purification process that can remove and/or inactivate a variety of viruses. Additionally, process efficiency and cost, among other factors, play a role in small- and large-scale manufacturing processes.
Many biopharma manufacturers are not yet utilizing the full loading potential of membrane adsorbers which serve to optimize efficiency and costs. Often, the full loading potential of membrane adsorbers are not determined with respect to the effect of protein load on the ability to achieve good virus retention (LRV).
This webinar will present a use case where a Sartobind® Q membrane adsorber was tested for loading capacity and the effect on virus using two different small-scale elements for downsizing.
- Downscaling of membrane adsorbers in a virus clearance stud.
- Aspects to consider in a virus clearance study to achieve good LRV results for a monoclonal antibody product.
- Financial impact of correct sizing of membrane adsorber.
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