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ADMA Biologics Announces Publication of an Article Describing the Manufacturing Process Optimization for its Commercial Products BIVIGAM® and ASCENIV™ in the Peer Reviewed Journal Immunotherapy
RAMSEY, N.J. and BOCA RATON, Fla., Oct. 17, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial
About this update from Adma Biologics Inc
[{"type":"text","content":"RAMSEY, N.J. and BOCA RATON, Fla., Oct. 17, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced the publication of an article describing the manufacturing process optimization of ADMA’s Intravenous Immunoglobulin (“IVIG”) products, BIVIGAM® and ASCENIV™ in the peer reviewed journal Immunotherapy.\n The article, as published in the October 2019 online-edition and the soon to be available November 2019 print-edition of Immunotherapy, describes the manufacturing process changes and improvements instituted by ADMA for both BIVIGAM® and ASCENIV™ following its acquisition of the Boca Raton, FL manufacturing facility. These improvements to ADMA’s manufacturing process resulted in engineering modifications and enhancements to procedural controls, and reductions in thermal, physical and chemical product stressors. The optimized manufacturing process demonstrates increased control of unit operations, process consistency and robustness, decrease in product variability and enhanced removal of impurities all of which lead to enhanced product quality. “We are very proud of the achievements made by the ADMA Biologics team and are pleased that BIVIGAM and ASCENIV are now commercially available. The diligent work of ADMA’s in-house development teams, including process development, analytical development, manufacturing, quality assurance and quality control, is evident from all the improvements to the manufacturing process described in this peer-reviewed publication,” stated Adam Grossman, President and Chief Executive Officer. “We hope that the improvements and manufacturing enhancements described in this peer-reviewed publication provide confidence to ADMA’s stakeholders.” About ASCENIV™ (Formerly RI-002) ASCENIV, immune globulin intravenous, human – slra 10% liquid, is a plasma-derived, polyclonal, intravenous immune globulin (“IVIG”). ASCENIV, which is indicated for the treatment of Primary Humoral Immunodeficiency or Primary Immune Deficiency Disease (“PI”) in adults and adolescents (12 to 17 years of age), was approved by the FDA on April 1, 2019 a...