: Scientists like Emil von Behring and Shibasaburo Kitasato discovered that the blood serum of immunized animals contained "antitoxins" (now known as antibodies). In 1891, the first child was treated with diphtheria antitoxin, a breakthrough that significantly reduced mortality from the disease. A Turning Point: Regulation and Safety (1901 – 1902)
Early production lacked oversight, leading to tragedies that spurred federal regulation of biological products.
: During World War II, Edwin Joseph Cohn developed a method to separate individual proteins from blood plasma, allowing for safer transfusions of specific components. The Recombinant Revolution (1970s – 1980s) Biologics, A History of Agents Made From Living...
Biologics now represent a massive portion of the pharmaceutical market, treating chronic conditions like cancer and autoimmune diseases.
: With the expiration of patents for original biologic drugs, "biosimilars"—highly similar but not identical copies—have entered the market to increase patient access and reduce costs. : Scientists like Emil von Behring and Shibasaburo
The advent of genetic engineering transformed biologics from natural extracts into "designer" therapies.
: In St. Louis, 13 children died of tetanus after receiving diphtheria antitoxin derived from a retired milk wagon horse named Jim, who had contracted tetanus. : During World War II, Edwin Joseph Cohn
: Researchers Paul Berg, Herbert Boyer, and Stanley Cohen developed techniques to insert genetic material from one organism into another. This allowed scientists to turn bacteria or animal cells into "factories" for producing human proteins.