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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. The LCA was responsible for the safety, purity, efficacy, and potency of all biologics before licensing.

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.

Testing for endotoxins in injectable biologics was revolutionized in Building 29A by a team led by Dr. Edward B. Seligmann and Dr. H. Donald Hochstein. Endotoxins are part of the outer membrane of the cell wall of Gram-negative bacteria and had been discovered to be the cause of fevers in some patients receiving injections.

They developed a new calibrated test, Limulus amebocyte lysate (LAL), for pyrogens (fever-causing endotoxins) using horseshoe crab blood instead of rabbits’ ears. LAL became the standard worldwide test for bacterial endotoxins.

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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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Dr. Seligmann and Mr. William H. Berkeley also developed a patented direct contact tray assembly for freeze-drying biologics.

When DBS was transferred administratively to the Food and Drug Administration (FDA), LCA became known as the Division of Product Quality Control.

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