Pavel Bondarenko

Amgen Inc.

For the last seventeen years, Dr. Pavel V Bondarenko has been involved in analytical development enabling Process Development of therapeutic proteins. He has contributed to analytical support of protein formulation, molecule/manufacturability assessment, process development, manufacturing and quality of both innovative and biosimilar therapeutic proteins including antibodies, bispecific antibodies, Fc-fusion proteins. His research included development of novel analytical methods with emphasis on biochemical (liquid chromatography, mass spectrometry) and biophysical characterization. He has advanced LC-MS methods for intact, reduced, native, top-down characterization of therapeutic proteins, peptide mapping, sequence variants analysis. In addition, Dr. Bondarenko progressed system biology of industrial mammalian cells and cell culture media with the goal of increasing productivity and controlling desired product quality, particularly glycosylation. He contributed to method development, elucidation of structure/function, mechanism of action, revealing clinically significant modifications and IND/BLA regulatory filings of several therapeutic proteins including panitumumab (Vectibix®), denosumab (Prolia®, Xgeva®), evolocumab (Repatha®), erenumab (Aimovig®).

Before Amgen, Dr Bondarenko was with Thermo Fisher Scientific involved in analytical instrumentation and method development in mass spectrometry area. His research included unveiling the label-free quantitation method for shotgun LC/MS/MS proteomics; low-pressure MALDI; nanoflow HPLC systems.
Dr. Bondarenko contributed to several scientific and technical innovations described in 8 patents, several pending patent applications and 70+ peer reviewed journal publications.