Sudhakar Voruganti is Business Development Director at Pfanstiehl, a world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients for biopharmaceuticals. At Pfanstiehl he provides commercial and technical support to the Biopharma customers. Sudhakar received his doctorate in Biochemistry and Molecular Biology from Oklahoma State University and has several years of Biopharma research experience in the areas of upstream process development and analytical method development. Prior to joining Pfanstiehl he worked for six years in the Biologics Analytical Method Development department at Bristol-Myers Squibb in New Jersey.
PS80 is a non-ionic surfactant routinely used in biotherapeutic formulations. PS80 prevents protein aggregates and protects proteins from denaturation from various stresses. However, there are challenges associated with PS80 as it is prone to degradation via oxidative or hydrolytic pathways. There are several root causes for PS80 degradation via oxidative pathway including transition metal contamination such as Fe and Cu. In this presentation we will discuss about mitigating risks with PS80 degradation using Pfanstiehl high purity, low endotoxin, low metal excipients.