Plasma Source: Committed to Safety

Kedrion Biopharma takes great pride in our excellent safety and quality record

Plasma for RhoGAM comes from a single plasma center, located in Williamsville, NY, called KEDPLASMA Somerset Labs. Plasma for RhoGAM is collected from approximately 500 donors and is manufactured in the US.

RhoGAM is made from human plasma. Products made from human blood may carry a risk of transmitting infectious agents (e.g., viruses, the variant Creutzfeldt-Jakob disease [vCJD] and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).

The human plasma that makes up RhoGAM undergoes a vigorous safety protocol, including donor selection and fractionation processes, a viral filtration step, and a viral inactivation process.2

KEDRION Biopharma takes great pride in our excellent safety and quality record

Plasma Safety and COVID

COVID-19 is a highly contagious coronavirus infection spread by respiratory droplets. It is caused by SARS-CoV-2, a single strand enveloped RNA virus.3

RhoGAM's patented Viresolve 180 process inactivates enveloped viruses, or those covered with a "fatty" outer coat similar to COVID-19.2

Steps to ensure plasma safety2

  • All donors are screened via medical history and laboratory testing for blood-borne pathogens
  • Only plasma that has passed virus screening is used for production. Each donation is screened for:
    • Hepatitis B surface antigen (HBsAg)
    • Hepatitis C antibodies (HCV)
    • Human immunodeficiency virus (HIV) 1 and 2
  • Nucleic Acid Testing (NAT) is used to detect:
    • Hepatitis B virus (HBV)
    • Hepatitis A virus (HAV)
    • HCV
    • HIV-1
    • Parvovirus B19
  • Plasma then undergoes fractionation via a modification of the cold alcohol procedure
  • Next, a patented Viresolve 180 filtration and other inactivation steps are performed to remove enveloped and non-enveloped viruses

For more information on the donor process, please see the full Prescribing Information.

The RhoGAM Donor Story

The RhoGAM story began with one generous donor

James Harrison was known as the "man with the golden arm." When his Rh antibodies were discovered by the team of scientists searching for the answer to Rh disease, he became the first plasma donor. Over his lifetime, he generously gave over 1,000 donations, a gift that has saved more than 2.4 million babies.5

Today, that spirit of generosity still lives on through Kedrion's donors.

RhoGAM is made with human plasma, or the yellow, straw-colored portion of the blood that transports antibodies. This plasma is collected from 500 donors at our KEDPLASMA facility.1 Most of our donors have been donating for 5 years, with some donating for more than 30 years.

The story continues

Kedrion is committed to eradicating hemolytic disease of the fetus and newborn throughout the world. Learn more about our dedication to global initiatives to educate and inform about Rh incompatibility at wirhe.org.

For more information on pregnancy, Rh-disease and anti-D therapy, visit pregnancy28.com.

For Professional resources to inform and educate on the global efforts to prevent Rh-disease, visit glowm.com.