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Testing for endotoxins (a toxin present in a bacteria cell that is released when the cell disintegrates) 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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Dr. Edward B. Seligmann (right) and William H. Berkeley demonstrate use of their recently patented freeze-drying tray. |
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Dr. Seligmann and Mr. William H. Berkeley also developed a patented direct contact tray assembly for freeze-drying biologics. Since DBS prepared and distributed each year 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.
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