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When the Division of Biologics Standards (DBS) was established in 1955, this centralized the biologics regulatory function at the National Institutes of Health (NIH) was centralized into one division rather than spread across multiple laboratories and institutes. However; however, for the first five years, the staff was still spread amongst multiple buildings on the NIH campus. In 1960, Building 29 was completed, and the staff was consolidated into one space. During the early 1960s, the laboratories and the sections within them were still being finalized and organized based on the growing needs and demands of vaccine production and other biologics regulations. By 1968, the DBS had the below seven laboratories.
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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 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.
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