ADMA Biologics Reports FDA Compliance Status for its
Manufacturing Facility has Improved
Human immune globulin is comprised of antibodies—Y-shaped proteins produced by B-cells that are used by the body's immune system to identify and neutralize foreign objects such as bacteria and viruses. IVIG is immune globulin purified from plasma by a manufacturing process called fractionation and administered intravenously to patients.
There are 2 types of immune globulins, standard and hyperimmune.
Standard immune globulins are manufactured using normal source plasma.
Manufactured using plasma obtained from donors who have elevated amounts [high- titers] of specific antibodies against a targeted pathogen.
Products currently available on the US market from various manufacturers include hepatitis B, tetanus, rabies, cytomegalovirus, and Rho(D) immune globulins, among others.
Additionally, IVIG is also used as therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis, skin diseases, and asthma. These latter uses are referred to as "off-label" or evidence-based uses because the FDA has not approved their use in these indications and promotion of such uses is not permitted by FDA unless approved by the agency.
Our wholly-owned subsidiary, ADMA BioCenters Georgia, Inc.("ADMA BioCenters"), operates 2 FDA-licensed, German Health Authority, or GHA, and Korean Ministry of Food and Drug Safety, or MFDS, certified source plasma collection facilities located in Norcross and Marietta, Georgia, which provide us with a portion of our blood plasma for the manufacture of RI-002. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale. Plasma collected from ADMA BioCenters' 2 Georgia facilities that is not used for making RI-002 is sold to third-party customers in the United States, and other locations where we are approved globally under supply agreements or in the open "spot" market. We have entered into long-term licensing and supply agreements with Biotest Aktiengesellschaft, or Biotest AG and their US subsidiary, Biotest Pharmaceuticals Corporation, or Biotest. At the same time, we granted Biotest AG an exclusive, royalty-bearing license to market and sell RSV antibody-enriched IVIG, if approved, in Europe and in other selected territories in North Africa and the Middle East.
Additional information may be obtained from the ADMA BioCenters website. http://atlantaplasma.com