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FDA Approves ADMA Biologics Increased IVIG Production

Expanded manufacturing process enables fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin.

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By: Kristin Brooks

Managing Editor, Contract Pharma

ADMA Biologics, Inc., a commercial biopharmaceutical company dedicated to specialty plasma-derived biologics, received approval from the U.S. FDA for the company’s expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin (IVIG).   The 4,400-liter IVIG plasma pool scale for BIVIGAM will allow ADMA to expand its manufacturing plant’s total processing capacity from 400,000 liters to an anticipated peak ...

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