UV-C irradiation was evaluated for its effectiveness on viral inactivation and impact on product quality attributes. The inactivation efficacy was evaluated by subjecting enveloped and non-enveloped viruses to a UV-C dose of 100 J/m2 in samples containing monoclonal antibody (mAb). Treatment at this dose resulted in effective inactivation of the non-enveloped virus (> 7 log reduction value, LRV), but ineffective inactivation of the enveloped virus (= 1 LRV). Effect on product quality was assessed by comparing a mAb that was purified with a process using UV-C irradiation to the same mAb purified with a process using low pH inactivation. Irradiation caused some oxidation, but the oxidized form was removed in subsequent purification steps. The quality of the purified product was therefore comparable to the mAb subjected to low pH inactivation. These results suggest that UV-C irradiation may be a viable viral inactivation technique, but requires careful evaluation of product quality.

Evaluation of UV-C irradiation as an alternative technique for virus inactivation in biopharmaceutical manufacturing

241st National Meeting (2011)

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