CUVITRU is a ready-for-use, sterile, fluid preparation of extremely detoxified and focused immunoglobulin G antibodies. The distribution of the IgG subclasses resembles that of normal plasma. CUVITRU has a broad spectrum of IgG antibodies against viral and bacterial agents. CUVITRU is produced from large swimming pools of human plasma. IgG prep work are purified from plasma swimming pools using a customized Cohn-Oncley cold ethanol fractionation procedure, along with cation and anion exchange chromatography. Evaluating against possibly infectious agents starts with the donor option process and continues throughout plasma collection and plasma prep work. Each specific plasma donation used in the manufacture of CUVITRU is collected only at FDA approved blood facilities and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen, and for antibodies to Human Immunodeficiency Virus and Hepatitis C Virus according to U. S. regulatory needs. As an additional precaution, mini-pools of the plasma are tested for the existence of HIV-1 and HCV by FDA accredited Nucleic Acid Testing and found to be adverse. The S/D process includes therapy with a natural blend of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18 C to 25 C for a minimum of 60 minutes. Artificial insemination virus spiking studies have been used to confirm the capability of the production process to inactivate and eliminate infections. To develop the minimal applicable virus clearance capacity of the production procedure, these virus clearance researches were performed under extreme conditions. Virus clearance researches for CUVITRU executed based on good laboratory practices are summarized in Table 7.
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