FDA Approves ADMA Biologics’ Expanded Manufacturing Process for Intravenous Immunoglobulin

0


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

ADMA Biologics, a commercial biopharmaceutical company, announced on April 28, 2021 that the FDA has approved its expanded manufacturing process for the fractionation and purification of a 4,400 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 facility to an expected peak flow rate of up to 600,000 L, ADMA said in a company press release. Additionally, ADMA will now have the ability to produce Bivigam at increased capacity with the same scale of manufacture, while using the same equipment, same release tests, disposables and labor.

“The FDA approval of the 4400 liter IVIG plasma pool scale production process is a 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 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 starting in the second half of the year.” 2021 and accelerating throughout 2022. “

Source: ADMA


Share.

Leave A Reply