FDA Approves ADMA Biologics Expanded Manufacturing Process for Intravenous Immune Globulin

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ADMA will now have the ability to produce Bivigam at increased capacity with the same manufacturing scale, while using the same equipment, release testing, disposables and labor.

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

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

“FDA approval of the 4400 liter IVIG plasma pool scale production process is an important milestone for the ADMA organization and will enable the company to produce significantly more IVIG for the US market and for patients living with immune deficiencies,” Adam Grossman, ADMA President and CEO, said in the press release. “The expanded production scale of the plasma pool allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the path to significant gross margin expansion potentially beginning within the second half of 2021 and accelerating through 2022.”

Source: ADMA

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