Rhophylac® is a sterile Rh₀(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh₀(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.

Plasma is obtained from healthy Rh₀(D)-negative donors who have been immunized with Rh₀(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of Rhophylac® is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of Rhophylac® is tested by FDA-licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. An investigational NAT for HBV is also performed on all source plasma used and found to be negative; however, the significance of a negative result has not been established. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).

Rhophylac® is produced by an ion-exchange chromatography isolation procedure7, using pooled plasma obtained by plasmapheresis of immunized Rh₀(D)-negative US donors. The manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton™ X-100) that is effective in inactivating enveloped viruses such as HIV, HCV, and HBV.8,9 Rhophylac® is filtered using a Planova® 15 nanometer (nm) virus filter that has been validated to be effective in removing both enveloped and non-enveloped viruses. Table 3 presents viral clearance and inactivation data from validation studies, expressed as the mean log10 reduction factor.

Table 3: Virus Inactivation and Removal in Rhophylac®

Rhophylac® contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac® has a purity greater than 95% IgG. Rhophylac® contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. Rhophylac® contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.

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