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 throughput of up to 600,000 liters. ADMA now has FDA approval to produce BIVIGAM at an expanded capacity with the same high quality as the previous manufacturing scale, while using the same equipment, release testing assays, disposables and labor force.
 
With this approval, ADMA additionally will now be able to offer BIVIGAM in two vial sizes, both the 50 mL and 100 mL configurations.
 
“The FDA approval of the 4,400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organization and will allow the Company to produce significantly more IVIG for the U.S. market and for patients living with immune deficiencies,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022.”