Web1 de abr. de 2015 · Virus clearance is an essential quality attribute of the downstream process of mAbs (Miesegaes et al., 2010). Inactivation methods as low pH and solvent/detergent treatment are well known and... Web12 de mai. de 2015 · Assessment of the viral clearance potential of a manufacturing process as a whole can be achieved by considering the viral clearance performance of its individual unit operations. Therefore, each step to be evaluated is “spiked,” or challenged with the appropriate preparation of a high-titer test virus.
Viral Clearance in the Manufacture of Biologics
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