Artifacts of Virus Filter Validation

May 06 2013

BioProcess International

Virus filters are used in biomanufacturing to ensure the safety of biopharmaceutical drug products. As part of filter implementation, manufacturers are required to validate that the filtration process can indeed remove virus.

It is difficult for the executers of virus filter validation studies to overcome the types of problems discussed in this article on the spot at the spiking laboratory. This article highlights areas to be explored during process development before the validation study to ensure that potential artifacts do not negate the scaled-down model. This article recommends that their effects be tested and known before a virus spiking study begins. The greatest value of solving these issues in advance is that the baseline run can be executed and virus spiking runs can be performed as scheduled, with no surprises. Armed with this advanced knowledge, in addition to available high-quality virus spikes and optimized virus spike percentages, your virus validation study can proceed smoothly to a successful endpoint — at which your target LRV and optimized filter throughput are both achieved.

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