ABSTRACT
Plasma-derived therapeutic proteins are parenteral biologics thatarepurifiedonan industrial scale. Allbiologics derived from human sources, such as plasma, carry the risk of viral contamination. The Committee for Proprietary Medicinal Products has issued guidelines on the selection of viruses to evaluate in validation studies. Certain process steps may be easier to model than others and duplicating the freeze dry/dry heat step at small scale is very difficult. All proteins have unique physico-chemical properties and stabilization requirements, so formulation and freeze drying cycle parameters must be customized for each new protein drug. For terminal viral inactivation steps, it is equally important to develop a formulation and freeze dry cycle that will not stabilize virus. During the freeze drying step, final containers are aseptically filled, the product is frozen and then the frozen solid is dried by the sublimation of ice under vacuum.
