BIOT 115 |
| Parvovirus retaining filters are being included in downstream monoclonal antibody processes in order to satisfy regulatory requirements for viral safety of biological products. One of the inherent problems with filtering mAb solutions through parvovirus removal filters is the low capacities associated with many commercially available filters. The capacity during commercial manufacture can largely be overcome by use of a depth filter as a prefilter, however, the implementation of this filter combination has been difficult due to challenges encountered during virus retention validation studies. In order to demonstrate size-based removal of viruses, the virus filter must be decoupled from the prefilter for virus spiking. This decoupling can lead to a dramatic decrease in validated throughput, ultimately increasing the cost for a step that accounts for about one-fifth of the entire downstream COGs. Solutions to the problem include exploring alternate spiking strategies, cleaning up the virus preparation, and evaluating alternate filters. Data will be presented in each of these areas, from evaluating the feasibility of using an inline spiking apparatus to overcome the filter decoupling issues, to exploring virus preparation cleanup options to reduce impurities introduced during spiking. Data will also be shown on a new parvovirus removal filter that demonstrates the ability to achieve high capacity and flux during virus retention validation studies and during protein processing. |
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Downstream Processing: Non-Chromatographic Separations
1:30 PM-4:20 PM, Monday, August 18, 2008 Philadelphia Marriott -- Grand Blrm Salon H, Oral
Division of Biochemical Technology |