Alpha (Prolastin)

Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) is a sterile, stable, lyophilized preparation of purified human Alpha1-Proteinase Inhibitor (alpha1-PI), also known as alpha1-antitrypsin. Prolastin (alpha) is intended for use in therapy of congenital alpha1-antitrypsin deficiency.

Prolastin (alpha) is prepared from pooled human plasma of normal donors by modification and refinements of the cold ethanol method of Cohn.1 Part of the fractionation may be performed by another licensed manufacturer. In order to reduce the potential risk of transmission of infectious agents, Prolastin (alpha) has been heat-treated in solution at 60±0.5°C for not less than 10 hours. However, no procedure has been found to be totally effective in removing viral infectivity from plasma fractionation products. In vitro studies designed to evaluate the capacity of the Prolastin (alpha) manufacturing process to remove/inactivate viruses have been conducted to provide additional assurance of the viral safety.