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Alpha1-proteinase inhibitor (human), modified process, refers to a highly purified, sterile preparation of human alpha1-proteinase inhibitor (A1PI) developed by Grifols using an advanced manufacturing process. A1PI, also known as alpha1-antitrypsin, is a critical serine protease inhibitor that protects lung tissue from degradation by neutrophil elastase. In patients with hereditary alpha1-antitrypsin deficiency (AATD), the lack of sufficient endogenous A1PI leads to uninhibited elastase activity, which destroys alveolar walls and results in progressive pulmonary emphysema. The "modified process" version (marketed as Prolastin-C) utilizes improved purification techniques to achieve higher protein concentration and purity compared to earlier formulations. It is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary A1PI deficiency, working to increase and maintain protective serum levels of the inhibitor.
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