Deamidation: a source of microheterogeneity in pharmaceutical proteins.
Most protein molecules undergo some degree of spontaneous deamidation in vivo. This process may also occur during the production, isolation, purification, formulation and storage of pharmaceutical proteins. Deamidation is a potential source of microheterogeneity for pharmaceutical proteins, and this is an important issue that needs to be addressed, not only by the manufacturers but also by the national control agencies. This article provides an overview of the scientific and regulatory issues pertinent to deamidation of pharmaceutical proteins.
Division of Biochemistry and Biophysics, Food and Drug Administration, Bethesda, MD 20892.
D T
DT
Liu
D011506:Proteins / Q000737:chemistry*
D011506:Proteins