Sterilization viral contamination

Prior to further processing of the bulk harvest, it should be tested for sterility, mycoplasma, and viral contamination. In the case of CHO cells, an in... 

It may be necessary to include intermediate steps within processing to reduce the bioburden and improve the efficiency of lethal sterilization cycles, or to prevent swamping of the preservative in a non-sterile medicine after manufacture. Some of the newer and fragile biotechnology-derived products may include chromatographic and/or ultrafiltration processing stages to ensure adequate reductions of viral contamination levels rather than conventional sterilization cycles. 

Sterility filtration of fluids containing a variety of raw materials, some of which may have been exposed to viruses, does not prevent the introduction of viral contaminants into the process. Only recently have membranes with pore sizes small enough to exclude passage of virus particles become available for industrial-scale operations. However, these membranes cannot be introduced into existing processes, without complex consequences on regula-... 

Cryoprecipitate may also be used for patients with factor VIII deficiency and von Willebrand disease if desmopressin is not indicated and a pathogen-inactivated, recombinant, or plasma-derived product is not available. The concentration of factor VIII and von Willebrand factor in cryoprecipitate is not as great as that found in the concentrated plasma fractions. Moreover, cryoprecipitate is not treated in any manner to decrease the risk of viral exposure. For infusion, the frozen cryoprecipitate unit is thawed and dissolved in a small volume of sterile citrate-saline solution and pooled with other units. Rh-negative women with potential for childbearing should receive only Rh-negative cryoprecipitate because of possible contamination of the product with Rh-positive blood cells. 

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