Biologics are products manufactured or extracted from biological sources such as living organisms, and may involve the use of recombinant DNA technology. Over the past five decades, uniform protocols have been developed for safety and toxicity testing of small molecules. On the other hand, biologics have a unique set of properties not usually present in small molecules. As such, the safety testing of biologics is more difficult and requires specialized evaluation.
Cloning human clotting factor IX | providing recombinant source of protein for Haemophilia B patients previously relied on hazardous blood derived product. Discover two sets of genetic mutations prevented key proteins from attaching DNA rare form of Haemophilia B. Lack of protein attachment to DNA turned off gene that produces factor IX which prevents excessive bleeding. | University of Oxford