Inactivation strategy for pseudorabies virus in milk for production of biopharmaceuticals

By selecting pseudorabies virus (PrV) as a model virus, this study assessed the feasibility of applying viral inactivation strategies to manufacturing medicinal products from the milk of transgenic sows. The efficacy of heat, acidic/alkaline and detergent treatments was also evaluated with respect to their ability to inactivate PrV in milk samples. Experimental results indicate that PrV was inactivated obviously at least 7.125 log10 for 30 min at 60 degrees C. At alkaline values of pH 10 and acidic value of pH 4, PrV infectivity was reduced to 3.625 log10 and exceeded 5 log10, respectively. Moreover, PrV virus was inactivated efficiently (> 3.875 log10) by using 0.25-1% of Triton X-100 treatment and without a loss of biological activity of the recombinant human coagulation factor IX (rhFIX).

of this study demonstrate the effectiveness of the proposed detergent inactivation method for PrV inactivation of rhFIX production from transgenic products, especially in milk materials.