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When the DBS was administratively transferred to the Food and Drug Administration (FDA) Bureau of Biologics in 1972, many of these labs remained the same, but under the title of Division instead of Laboratory. During the 1980s there was significant reorganization, and many divisions were combined, abandoned, or changed names entirely. 

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This division has seven labs within it, including pertussis, allergenic products, bacterial toxins, bacterial polysaccharides, mycobacteria and cellular immunology, mycoplasma, and cellular physiology. 

Allergenic Products 

Allergenic investigations by the FDA Bureau of Biologics in 1978 focused on standardized in vitro and in vivo assays of allergenic potency. The former tests under development included radial immunodiffusion, isoelectric focusing, and allergen coupling compared to radioactive or enzyme-labeled antibody. The in vivo assays under study were based on the skin tests used in allergic patients as well as the immunogenicity of allergenic extracts following their use in the immunotherapy of allergic disease.

Mycoplasma

By the early 1980s the FDA Bureau of Biologics had a laboratory on mycoplasma, but scientists had been investigating mycoplasmas since before the DBS moved into Building 29 in 1960. Mycoplasmas are single-celled bacteria lacking a cell wall and are able to penetrate other cells; they constituted a challenging source of contamination of cell cultures. A DBS regulation in 1960 required manufacturers to test for mycoplasmas in human viral products that relied on cell cultures.  As mycoplasma tests advanced over the years, the testing rules changed accordingly. With the emergence of hybridoma technology to generate biological products (in which a target antigen is injected into a mouse, a resulting antibody-producing cell is harvested from the spleen, and the splenic cell fused with a tumor cell to produce the desired antibody), mycoplasmas found their way into the new products from this technology, such as monoclonal antibodies. The Bureau of Biologics’ rulemaking and research interests by the 1980s thus had shifted to controlling mycoplasma contamination of the products developed from this newer approach to biologics production

When the biologics regulation function emerged after the many organizational changes at the FDA as CBER, it then included an Office of Establishment Licensing, an Office of Blood Research and Review, an Office of Vaccine Research and Review, an Office of Therapeutic Research and Reviews, and the Office of Compliance.