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

Prolastin 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 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 manufacturing process to remove/inactivate viruses have been conducted to provide additional assurance of the viral safety profile as shown in the table below.

The specific activity of Prolastin is ³0.35 mg functional alpha1-PI mg protein and when reconstituted, as directed the concentration of alpha1 PI is ³20 mg mL. When reconstituted Prolastin has a pH of 6.6- 7.4 a sodium content of 100-210 mEq-L a chloride content of 60-180 mEq/L a sodium phosphate content of 0.015- 0.025 M, a polyethylene glycol content of not more than (NMT) 5 ppm, and NMT 0.1% sucrose. Prolastin contains small amounts of other plasma proteins including alpha₂ plasmin inhibitor, alpha1-antichymotrypsin, C₁- esterase inhibitor, haptoglobin, antithrombin III, alpha₁-lipoprotein albumin and IgA. ¹

Each vial of Prolastin contains the labeled amount of functionally active alpha₁-PI in milligrams per vial (mg/vial), as determined by capacity to neutralize porcine pancreatic elastase.¹ Prolastin contains no preservative and must be administered by the intravenous route.

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