Donor Screening
ONE DEDICATED COLLECTION SITE
With RhoGAM® Brand, product safety starts with the donor. Unlike other manufacturers that draw plasma from multiple collection sites—and thousands of anonymous donors—source plasma for RhoGAM® Brand comes from a small, select group of long-standing donors. They’re recognized members of the RhoGAM® Brand family who’ve been coming to the same donation center once or twice a week for 10, 20, even 30 years. They eagerly endure routine health screening and monitoring because they believe in RhoGAM® Brand.
Some of the donors have personal reasons for participating in the program. They were Rh-negative mothers in the era before RhoGAM® Brand was developed and they gave birth to Rh-positive infants who were victims of HDN. Some of their babies were born mentally retarded, others died in utero or shortly after birth. A few of the most senior donors are women who lost all of their children to HDN, and they’ve dedicated themselves to ensuring that no family will ever again have to go through what they had to endure.
Highly controlled donor program
- Plasma for RhoGAM® Brand is typically drawn from a limited pool (approximately 300 donors) at Somerset Labs, an FDA-licensed donation center located near Buffalo, NY.
- Other manufacturers of human IgG and blood products use as many as 10,000 donors1
- 25% of RhoGAM® plasma donors have been contributing for more than ten years, some for as long as 30 years
- The small, well-known donor pool size reduces the likelihood of it containing infectious agents
- Donated plasma is screened for viruses using approved by the FDA advanced testing techniques
Reference: 1. Lynch TJ, Weinstein MJ, Tankersley DL, et al. Considerations of pool size in the manufacture of plasma derivatives. Transfusion. 1996;36:770-775