Table V

PPV Titer of Individual Grab Samples from the Experiment with Significant PPV Breakthrough

SamplesDescriptionTCID50 Titer (log10/mL)LRF*
Spiked loadVirus-spiked mAb-1 charged onto the filter6.43Not applicable
Grab 1Permeate (∼1.0 mL) collected at the beginning≤–0.20≥6.63
Grab 2Permeate (∼1.0 mL) collected at the mid-point≤–0.20≥6.63
Grab 3Permeate (∼1.0 mL) collected at the end≤–0.20≥6.63
Pooled permeatePooled permeate included the filtrate from buffer flushing3.802.60
Hold controlProcess control6.300.13
  • * LRF for pooled permeate was calculated by taking into the consideration of volumes of spiked load and pooled permeate plus flushing filtrate. LRF for other samples were simply based on TCID50 titer.