contractpharmaJuly 07, 2020
Tag: ADMA Biologics , FDA , plasma collection center
ADMA Biologics Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, has announced the commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Knoxville, TN. ADMA has also submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this second plasma collection center.
“We are extremely pleased to announce the opening and commencement of operations at our second and newest ADMA BioCenters plasma collection facility,” said Adam Grossman, president and CEO of ADMA. “The opening of the Knoxville center is an important step in our expansion plans and puts us on track to achieve our goal of opening five to 10 new plasma collection centers by the end of 2022.”
This new plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, a 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.
The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this second plasma facility in mid-2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products.
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