Table VI

An Evaluation of the Impact of Vendor Resin Expiry on Viral Clearance during the Lifetime of Protein A and Anion-Exchange Chromatography Resins. Data provided by Brett Hanna, Rebecca Smith, Christopher Rode, and Michael Spade.

Unexpired ResinExpired Resin
Reused Resin (LRV)Control Resin (LRV)Normalized LRV (%)Reused Resin (LRV)Control Resin (LRV)Normalized LRV (%)
Protein A chromatography, MAb-2
Ecotropic Recombinant Virus of mice (ERV)6.66.51026.66.5102
Polio4.34.31004.44.3102
MVM4.43.71194.23.7114
Yield decayNo46% (P < 0.0001)
DBC decay58% (P = 0.03)68% (P = 0.01)
Protein A chromatography, MAb-3
ERV4.44.41004.64.4105
Polio4.53.71225.03.7135
MVM2.74.0684.34.0108
Yield decay14% (P < 0.0001)13% (P < 0.0001)
DBC decay21% (P = 0.01)18% (P = 0.004)
Anion-exchange chromatography, MAb-2
ERV5.55.6984.75.684
Reovirus5.85.81006.55.8112
MVM4.64.41054.64.4105
Yield decayNoNo
Ion capacity decayNoNo
Anion-exchange chromatography, MAb-3
ERV5.66.6855.66.685
Reovirus6.36.31006.26.398
MVM6.96.31106.66.3105
Yield decayNoNo
Ion capacity decayNoNo