The company manufactures ASCENIV, a plasma-derived intravenous immunoglobulin (IVIG) product, using a proprietary fractionation process under HHS License No. 2019. Their manufacturing process incorporates a patented plasma donor screening methodology and a tailored plasma pooling design that blends normal source plasma with plasma from donors exhibiting high levels of neutralizing antibody titers to RSV, identified through a proprietary microneutralization testing assay. High-titer or "hyperimmune" plasma, meeting internal and regulatory specifications for ASCENIV, is found in less than 10% of donor samples tested. Commercial sales of ASCENIV began in October 2019. In fiscal year 2023, manufacturing capacity expanded to a 4,400-liter production scale, enhancing margins and capacity. In June 2025, the company filed a supplemental Biologics License Application to expand ASCENIV's label to include pediatric patients aged two years and older, with FDA approval anticipated in the first half of fiscal year 2026.
Adma Biologics Inc's Comment on Supply Chain
The company manufactures ASCENIV, a plasma-derived intravenous immunoglobulin (IVIG) product, using a proprietary fractionation process under HHS License No. 2019. Their manufacturing process incorporates a patented plasma donor screening methodology and a tailored plasma pooling design that blends normal source plasma with plasma from donors exhibiting high levels of neutralizing antibody titers to RSV, identified through a proprietary microneutralization testing assay. High-titer or "hyperimmune" plasma, meeting internal and regulatory specifications for ASCENIV, is found in less than 10% of donor samples tested. Commercial sales of ASCENIV began in October 2019. In fiscal year 2023, manufacturing capacity expanded to a 4,400-liter production scale, enhancing margins and capacity. In June 2025, the company filed a supplemental Biologics License Application to expand ASCENIV's label to include pediatric patients aged two years and older, with FDA approval anticipated in the first half of fiscal year 2026.
Sources:
Adma Biologics Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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