FDA Approves ADMA Biologics’ Expanded Manufacturing Process for Intravenous Immune Globulin

ADMA Biologics, a commercial biopharmaceutical company, announced on April 28, 2021 that FDA has approved its expanded manufacturing process for the fractionation and purification of a 4400-L plasma pool for the manufacture of its intravenous immune globulin (IVIG), Bivigam.

The approval allows for the company to expand its manufacturing plant’s total processing capacity from 400,000 L to an anticipated peak throughput of up to 600,000 L, ADMA said in a company press release. Additionally, ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

“The FDA approval of the 4400-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 US market and for patients living with immune deficiencies,” said Adam Grossman, president and CEO of ADMA, in the press release. “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.”