Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.

This disclosure relates to methods for use in inactivating viruses. The virus inactivation methods are for use in continuous process manufacturing of a biologic such as an antibody, and include separating an eluate using a column, subjecting said eluate to an orthogonal treatment of low pH and detergent simultaneously wherein, the time for viral inactivation is reduced. In addition, the detergent can be added to buffer system in purification process to achieve the same effect. The biologic in each treatment case is retained.

Detergents for use to inactivate enveloped viruses, including detergents that are considered eco-friendly that can be used in biomanufacturing operations.

The present invention relates to a novel method for improving the viral safety of liquid Factor VII compositions, in particular those comprising active Factor VII polypeptides (a Factor VIIa polypeptide).

The present invention relates to a novel method for improving the viral safety of liquid Factor VII compositions, in particular those comprising active Factor VII polypeptides (a Factor VIIa polypeptide).

Aspects of the invention provide therapeutic recombinant protein preparations and methods of preparing therapeutic recombinant protein, which methods include contacting recombinant protein preparations with zwitterionic detergent at or above critical micelle concentration of the detergent.

The present invention relates to a novel method for improving the viral safety of liquid Factor VII compositions, in particular those comprising active Factor VII polypeptides (a Factor VIIa polypeptide).

Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.

This disclosure relates to methods for use in inactivating viruses. The virus inactivation methods are for use in continuous process manufacturing of a biologic such as an antibody, and include separating an eluate using a column, subjecting said eluate to an orthogonal treatment of low pH and detergent simultaneously wherein, the time for viral inactivation is reduced. In addition, the detergent can be added to buffer system in purification process to achieve the same effect. The biologic in each treatment case is retained.

Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.