Laboratory of Control Activities
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 National Institutes of Health (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 formation of the LCA and DBS was also likely related to the change in regulations regarding polio vaccine production as well.
LCA was 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.
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.
Dr. Seligmann and Mr. William H. Berkeley also developed a patented direct-contact tray assembly for freeze-drying biologics. Since DBS annually prepared and distributed approximately 6,000 standard or reference preparations to establishments throughout the world for use in biologics standardization, it was essential that this material be meticulously and uniformly prepared. Their new tray had the advantage of allowing each vial to directly touch the freeze-dryer shelf, ensuring uniform freezing and heating for all of the vials when put into the chamber-type dryer.
Dr. Seligmann was appointed chief of the Laboratory of Control Activities by DBS Director, Dr. Roderick Murray, in 1968. He had served as the chief of the Section on Reference Standards since his arrival at the NIH in 1959.
When DBS was transferred administratively to the Food and Drug Administration (FDA), LCA became known as the Division of Product Quality Control.
1968 publication "The Division of Biologics Standards" (Public Health Service Publication No. 1744) by Dr. Roderick Murray