Disease state plasma can be extremely difficult to find and collect. In the United States, most human blood products must come from donors bled at FDA registered blood donor centers, regardless of the material’s intended use. Unlike normal human plasma, which is collected routinely for use in manufacturing licensed in vivo blood products for humans, disease state plasma comes from people suffering from an acute infectious disease or a chronic medical condition and is used to manufacture in vitro diagnostic products. Only a handful of donor centers in the US can legally bleed donors with a clinically identified disease. Any donor center that wishes to draw specialty antibodies from a disease state donor must amend its license to include and list each disease/disorder. Since most centers do not list these disorders on their license, they cannot bleed specialty plasma donors.
This means that potential donors must sometimes travel substantial distances to donate. In addition, these donors must be healthy enough to donate and meet all acceptance criteria set by each donor center and the FDA. The FDA does not distinguish between in vivo and in vitro use and implements these regulations to protect the donor’s health as well as the blood supply. In addition to meeting acceptance criteria, a potential donor must also have elevated antibody titer(s) to be of value in the industry. Due to all of these factors, it can be exceedingly complicated to find, qualify and bleed a specialty plasma donor.
