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Laboratory of Control Activities

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The Laboratory of Control Activities (LCA) was formed in 1955 when the Division of Biologics Standards (DBS) was formed, as the continuation of a biologics regulatory function that had existed in what is now known as the NIH since 1902. Biologics include vaccines, blood and blood products, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

The LCA was responsible for the safety, purity, efficacy, and potency of all biologics before licensing. They were also responsible for the development and distribution of the United States standard and reference preparations used in establishing potency of biologics.

The LCA was formed—along with the DBS itself—in the wake of the Cutter polio vaccine incident.  The organizational response to that (biologics regulation existing independently within NIH as DBS). This was likely related to the change in regulations regarding polio vaccine production as well.


Located in Building 29, Fourth Floor from 1960 to 1967, then moved to Building 29A, First Floor when it opened in 1967.

LCA included multiple sections within the lab, including Reference Standards, Control Test, Pyrogens, and in 1971 also included an Analytical Chemistry section.

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two doctors in lab coats examining a tray of tubes, half-inserted into a large device which resembles an oven.

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Dr. Edward B. Seligmann (right) and William H. Berkeley demonstrate use of their recently patented freeze-drying tray.

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Photo by Tom Joy. The NIH Record 12.13.1966

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