Development of API Manufacturing Process
American Red Cross (ARC)
Rosalyn (Virginia)
Kamada Ltd.
Rehovot (Tel Aviv & Central)
Project description
Alpha-1 Anti-Trypsin (AAT) Protein needed for patients whose liver is unable to naturally synthesize it, and administer it to patients…
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Alpha-1 Anti-Trypsin (AAT) Protein needed for patients whose liver is unable to naturally synthesize it, and administer it to patients by infusion. The joint project between Kamada and the American Red Cross and funded by the BIRD Foundation, to develop Alpha1-Proteinase Inhibitor from Human source for Alpha-1-Antitrypsin Deficiency patients was completed with the preparation of clinical grade of the Active Pharmaceutical Ingredient and IND submission to the FDA. This submission led to successful clinical trials completed with FDA approval in July 2010. Kamada has reached a major licensing agreement with Baxter International to distribute intravenous Alpha 1 Antitrypsin Product for the treatment of hereditary Alpha-1 antitrypsin Deficiency which is distributed under the trade name “Glassia™”.
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