ADMA Biologics Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced that it has received U.S. FDA approval for its ADMA BioCenters plasma collection facility located in Maryville, Tennessee. This plasma collection facility commenced operations and initiated source plasma collection in the fourth quarter of 2020. With this approval, this facility is FDA-licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.
“The approval of this plasma collection facility represents both another milestone regulatory achievement as well as an important step in ADMA’s ambitions to further secure raw material plasma supply and enhance end-to-end control of manufacturing operations,” said Adam Grossman, President and Chief Executive Officer of ADMA. “ADMA has eight plasma collection facilities under its corporate umbrella, including three FDA-approved facilities, with five of those facilities now open and collecting plasma and two additional Biologics License Applications (“BLA”) filings anticipated over the remainder of 2021. In total, ADMA remains on track to have 10 or more FDA-approved plasma collection facilities by 2024. Along with the extension of third-party supply agreements through year-end 2022, as well as the anticipated yield enhancements resulting from our recent implementation of the Haemonetics’ NexSys Persona® technology, ADMA believes it is insulated from broader market plasma collection and pricing fluctuations. The Company remains well-positioned to ensure the continuity of our supply chain and our plasma products supply.”
This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers. This center is approved to use the state-of-the-art Haemonetics NexSys Persona® plasma collection system.
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