ADMA Biologics Reports FDA Compliance Status for its
Manufacturing Facility has Improved

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Innovation for the immunocompromised

Our goal is to be a leader in developing and commercializing specialized, targeted, plasma-derived therapeutics to extend and enhance the lives of individuals who are naturally or medically immunocompromised.

Our Patent

During the second quarter of 2015, we received a notice of allowance from the US Patent Office, or USPTO, for our RI-002 patent filed under U.S. patent application 14/592,721 entitled ‘Compositions and Methods for the Treatment of Immunodeficiency,’ which extends through January 2035. During the third quarter of 2015 our U.S. Patent 9,107,906 was issued by the USPTO. This patent describes methods by which the blending of plasma obtained from normal donors with plasma obtained from donors selected to have high levels of neutralizing antibody titers to RSV form a unique antibody enriched plasma pool and provide for the standardization of the levels of anti-RSV antibodies in the RI-002 final product. Additionally, our patent covers methods of producing hyperimmune globulin compositions to multiple pathogens.

The Difference Is In The Donors

Discover the Difference of Our Patented Immunotechnology

Meets FDA Requirements for IVIG Products

  • Donor pool size > 1,000
  • Minimum titers to certain infectious agents - release testing specifications
  • Polyclonal antibodies meet FDA requirements

A Unique Plasma Pool And Process

  • Plasma pool derived from blending normal source plasma and high-titer antibody rich plasma
  • Process yields an IG product which meets the FDA release specifications for treatment of patients with PIDD as well as specified levels of RSV antibodies in the final product preparation
  • Process is protected by an issued patent to eliminate lot-to-lot variability of certain specific polyclonal anti-pathogen antibodies

Our Proprietary Microneutralization Assay

Our proprietary microneutralization assay allows us to identify and isolate donor plasma with high-titer RSV antibodies and to standardize RI-002's antibody profile.

Leveraging our immunotechnology platform, we intend to develop additional plasma-derived products through direct R&D and potential licensing opportunities. These follow-on products may include infectious disease-specific IVIG product candidates targeting immunocompromised patients with PIDD as well as transplant patients. Future product candidates could focus on the management of chronic viral and bacterial infections.