Alpha Therapeutic Corporation

Raja R Mamidi

Kazuo Takechi

Andranik Bagdasarian

Gorgonio Canaveral

Charles M Heldebrandt

Yahiro Uemura

Hirokazu Ito

Mauro C Mojica

Sunnie Park

Takashi Goto

Leticia R Regis

A method is provided for removing citrate, aluminum, and other multivalent ions and contaminants from proteins by adjusting the pH of a solution containing the protein to a pH from about 7 to about 10, and diafiltering the pH-adjusted solution against aqueous solutions which have a low level of ions.

Method to remove citrate and aluminum from proteins

A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by fractionating an impure gamma globulin solution and then treating the purified gamma globulin, in any order, with a solvent-detergent for viral inactivation and a heat treating for viral inactivation. Thereafter, denatured impurities, residual solvent and aggregate generated by the heat treatment are removed from the gamma globulin.

Method for preparing dual virally inactivated immune globulin for intravenous administration

A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by fractionating an impure gamma globulin solution and then treating the purified gamma globulin, with a solvent-detergent for viral inactivation and a heat treating for viral inactivation. Thereafter, denatured impurities, residual solvent and aggregate generated by the heat treatment are removed from the gamma globulin.

Method for repairing dual virally inactivated immune globulin for intravenous administration

A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by heat treating for viral inactivation and fractionating an impure gamma globulin solution and then treating the purified gamma globulin with a solvent-detergent for further viral inactivation. In a continuous process disclosed herein, partially purified gamma globulin solids is not recovered as an intermediate product during the disclosed process. In the continuous process, the fractionation to obtain a purified gamma globulin solution is carried out without precipitation of the desired gamma globulin.

Manufacturing method for intraveneously administrable immune globulin

A method of preparing an IgA rich preparation comprising exposing a plasma fraction to an amino acid, organic salt or inorganic salt with optional chromatographic treatment yielding a product suitable for use in medical conditions treatable with IgA.

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Pomona, CA, United States of America

Raja R Mamidi