Summary of the Viral Clearance in the Paired Observations Using Concurrent or Non-Concurrent Testing Approaches
Comparison of the Cycled and the Naïve Resins | Protein A (Number of Paired Observations) | AEX (Number of Paired Observations) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Agarose, Caustic Stable | Agarose, Not Caustic Stable | C.P.G., Not Caustic Stable | AEX B/E | AEX FT | ||||||
Non-Concurrent | Concurrent | Non-Concurrent | Concurrent | Non-Concurrent | Concurrent | Non-Concurrent | Concurrent | Non-Concurrent | Concurrent | |
The Cycled Resin Clearance Exceeds the Naïve Resin Clearance by >1 LRF | 1 | 0 | 7 | 1 | 4 | 5 | 1 | 0 | 6 | 1 |
The Cycled Resin Clearance Is Within |1| LRF of the Naïve Resin | 12 | 7 | 21 | 18 | 4 | 15 | 56 | 18 | 34 | 26 |
The Cycled Resin Clearance Is Less Than the Naïve Resin by >1 LRF | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |