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Each vial contains sufficient anti-Rho(D) (approximately 300 mcg*) to effectively suppress the immunizing potential of 15 mL of Rho(D)-positive red blood cells. The potency is equal to or greater than that of the US Food and Drug Administration Reference Rho(D) immune globulin.
Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose, treated with solvent/detergent, is a sterile solution of immune globulin containing antibodies to Rho(D) for IM administration. It contains no preservative. It is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hrs. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. It is then incubated in the final container for 21-28 days at 20-27°C.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose has been validated in laboratory studies. Human immunodeficiency virus type I (HIV-1) was chosen as the relevant virus for blood products; bovine viral diarrhea virus (BVDV) was chosen to model hepatitis C virus; pseudorabies virus (PRV) was chosen to model hepatitis B virus and the herpes viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at 2 steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: The precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.
* A full dose of Rho(D) immune globulin (human) has traditionally been referred to as a "300 mcg" dose and this dosage is employed here for convenience in terminology. It should not be construed as the actual anti-D content. Each full dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) must contain at least as much anti-D as 1 mL of the US Reference Rho(D) immune globulin. Studies performed at the FDA have shown that the US Reference contains 880 iu of anti-D per mL. When the conversion factor determined for the International (WHO) Reference Preparation is used, 620 iu/mL is equivalent to 184 mcg/mL of anti-D.
