Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

Laboratory of Blood and Blood Products

In the 1950s, the NIH Blood Bank was part of the Laboratory of Blood and Blood Products. At some point in the late 1950s or early 1960s, the hospital blood bank (which was located in the basement of the Clinical Center) was administratively separated out from the Laboratory of Blood and Blood Products and became part of the Clinical Center (Department of Transfusion Medicine).

Blood products can include blood, red blood cells, fresh/frozen plasma, platelets, plasma derivatives, albumen, immune globulins, clotting factor concentrates, things that are made by recombinant DNA technology, reagents that test for infectious disease or are used to type the blood, and even the blood bank software used to keep track of the donations.

The Laboratory of Blood and Blood Products was located in Building 29, first floor. In the late 1960s, they also acquired a few rooms on the fourth floor of Building 29.

When the Division of Biologics Standards (DBS) was administratively transferred to the Food and Drug Administration (FDA) in 1972, telephone directories suggest that the lab moved to the second and third floors of Building 29. The name also changed from Laboratory to Division, reflecting the FDA’s organizational structure.

After the administrative transfer of the DBS from the NIH to the Food and Drug Administration (FDA) in 1972, Dr. Lewellys Barker moved from the Laboratory of Virology and Rickettsiology to the Division of Blood and Blood Products where he worked from 1973 to 1978. Dr. Barker researched the Hepatitis B virus and its test and vaccine. Dr. John Finlayson and Madge Crouch also worked in Blood and Blood Products.

Blood and Blood Products:  Hemophilia

An early blood research project in the FDA Bureau of Biologics concerned providing increased supplies of antihemophilic factor through two sources, antihemophilic factor concentrate (AHF) and cryoprecipitated antihemophilic factor (CAF).  For example, staff evaluated the possibility of producing CAF from fresh frozen single-donor plasma that was beyond its use date by assaying samples of donor frozen plasma at different time periods.  The Bureau also contracted with the American Red Cross to investigate if AHF could be harvested from blood stored up to about a week. These studies were ongoing.

In the mid-1970s, interest in developing improved assays for potency and safety for products used in blood clotting diseases led the Bureau to launch a study into purification and other elements associated with blood components that play a role in clotting, particularly Factor IX (associated with Christmas disease), the clinical use of which had been problematical. An animal model was identified to help in the observation of in vivo clotting characteristics, and in vitro observations were facilitated through electron microscopy.  

Data from the early 1980s indicated that nearly a third of those with hemophilia who die have severe liver disease, either as the cause of death or a contributing factor. So, the approval of Travenol Laboratories’ heat-treated Factor VIII (the antihemophilic factor) in 1983 was an especially important move for those with this disease.  Animal models used by the firm indicated that heat decreased the infectivity of Hepatitis B and eliminated hepatitis C. 

The Center for Biologics Evaluation and Research (CBER) licensed Monoclate late in 1987, the first blood product purified by biotechnological techniques, an antihemophilia factor. This was produced from normal human plasma with monoclonal antibodies to extract Factor VIII:C from plasma. This treated hemophilia A, which affects more than 20,000 patients at that time.

The development and licensing of recombinant Factor VIII in 1992 and 1993 eliminated the possibility that the 10,000 Americans suffering from hemophilia A would face the possibility of the transmission of hepatitis or AIDS. Recombinate was the first such product, licensed in Dec. 1992, and Kogenate received its license in the following February.

Initial results of a 1999 Bureau of Biologics analysis of a recombinant antihemophilia factor.  FDA History Office

During the late 1990s, the Division of Blood and Blood Products no longer appeared in telephone directories. It may have been reorganized under Hematology or the Division of Blood Application.

By 2000, there was both the Division of Blood Application and the Office of Blood Research and Review at the FDA’s Center for Biologics Evaluation and Research (CBER).