Rubella HPV77 Strain Purified Virus, UV-Inactivated

Virus Preparation: Purified Virus

Cell Line for Propagation: Vero

Suspending Buffer: Phosphate Buffered Saline (PBS), 250 mM sucrose, 25 µg/ml gentamicin.

Final Fill Volume: Varies by lot

Virus Particle Count: Varies by lot

Protein Concentration: [varies by lot] mg/mL by Pierce BCA protein method using BSA standard. Alternative methods for determining protein concentration may give different values.

Sterility: Bacteria, yeast, fungi and Mycoplasma were not detected by our assay methods.

HA Titer: Varies by lot

Validation of Inactivation: Confluent monolayers of Vero cells were infected with undiluted to 10⁴ dilutions of inactivated virus stock in four replicates and incubated for a period of 7 days. Active Rubella virus stock of the same lot and mock-infected Vero cells were included as positive and negative controls, respectively, for the assay. Cultures were incubated for a period of 7 days, and examined microscopically for the evidence of virus-specific CPE. The culture supernatant of active and inactivated virus were tested by HA using day old chick RBC. Only the active virus culture supernatant was positive for HA.This lot of inactivated Rubella virus stock, undiluted to 10⁴ dilutions, did not yield any infectious virus. The active virus stock of the same lot yielded infectious virus up to a 10⁶ dilution.