Zemaira (Alpha 1-Antitrypsin) - Description

DESCRIPTION

Alpha₁-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha₁-proteinase inhibitor (A₁-PI), also known as alpha₁-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.

Zemaira™ is supplied as a sterile, white, lyophilized powder to be administered by the intravenous route. The specific activity of Zemaira™ is >/=0.7 mg of functional A₁-PI per milligram of total protein. The purity is >/=90% A₁-PI. Following reconstitution with 20 mL of Sterile Water for Injection, U.S.P., each vial contains approximately 1000 mg of functionally active A₁-PI, 81 mM sodium, 38 mM chloride, 17 mM phosphate, and 144 mM mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH. Zemaira™ contains no preservatives.

Each vial of Zemaira™ contains the labeled amount of functionally active A₁-PI in milligrams as stated on the vial label as determined by its capacity to neutralize human neutrophil elastase.

The plasma used in the manufacture of this product has been tested and found to be nonreactive to HBsAg, nonreactive for antibody to Hepatitis C Virus (Anti-HCV), and negative for antibody to Human Immunodeficiency Virus (Anti-HIV-1/HIV-2).

Two viral reduction steps are employed in the manufacture of Zemaira™: pasteurization at 60°C for 10 hours in an aqueous solution with stabilizers and two sequential ultrafiltration steps. These viral reduction steps have been validated in a series of in vitro experiments for their capacity to inactivate/remove Human Immunodeficiency Virus (HIV), Hepatitis A Virus (HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus B19, and Pseudorabies Virus (PRV) as a non-specific model virus to cover a wide range of physiochemical properties of the viruses studied. Total mean log₁₀ reductions range from 6.8 to >12.2 log₁₀ as shown in Table 1.