Liaison(s): Y. John Wang
Genentech, founded in 1976 by Robert Swanson and Dr. Herbert Boyer, is considered to be the first biotechnology company. Currently, Genentech is one of the leading biotech companies in the world and possesses a broad portfolio of life-saving medicines along with many more drug candidates in its pipeline. This is Genentech’s first Team Masters Project and it is centered on investigating the causes and effects of Reactive Oxygen Species (ROS) in protein therapeutic formulations. Protein oxidation is a well known cause of structural modification, which in turn leads to a loss of effective potency. Various formulation chemicals and physical conditions contribute to the formation of ROS. Therefore understanding ROS formation and effects in vitro will allow for the formulation of more stable protein pharmaceuticals. This will provide Genentech with a competitive advantage in the manufacture and sale of low cost and high quality protein drugs. The generation and effects of specific ROS have been extensively studied in vivo, however, there is a critical lack of study into the generation of these ROS from chemicals commonly used in the manufacture of biopharmaceuticals. The Genentech TMP group explored published literature in order to develop various assays that measure four different ROS in formulations. The group standardized and tested each assay’s validity on several concentrations of Polysorbate 20 (or Tween 20), a commonly used surfactant in formulations. After the incubation of different preparations of Tween 20 at 5°C, 30°C, and 40°C over one week, the group measured the trend of ROS production at various time intervals. Next, assays and incubation times were adjusted to better capture individual ROS over a one month period. To conclude the TMP, the group arranged and prepared the results for future submission to a peer-reviewed scientific journal.