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Pavel Bondarenko

Scientific Director 
Process Development

Pavel joined Amgen in 2002.  He has held positions as Senior Scientist, Principal Scientist and is currently Scientific Director within Process Development. His responsibilities include analytical method development for therapeutic proteins during all stages of drug development and analytical support of manufacturability assessment, process development, manufacturing and quality for both innovative and biosimilar protein drugs.  Pavel supports the development of new analytical methods with emphasis on biochemical (mass spectrometry, chromatography) and biophysical characterization of therapeutic proteins, therapeutic antibodies, bispecific antibodies, antibody drug conjugates, and Fc-fusion proteins.  His responsibilities also include qualification and transfer of established methods to high-throughput implementation, process analytical technology and quality control labs. Pavel’s accomplishments include scientific and technical innovations with 9 patents, several pending patent applications and 70+ peer reviewed journal publications.

Featured Publications

Shi, R. L.; Xiao, G.; Dillon, T. M.; Ricci, M. S.; Bondarenko, P. V. Characterization of Therapeutic Proteins by Cation Exchange Chromatography-Mass Spectrometry and Top-Down Analysis. mAbs 2020, 12 (1), 1-12. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188404/

Kang, S.; Zhang, Z.; Richardson, J.; Shah, B.; Gupta, S.; Huang, C. J.; Qiu, J.; Le, N.; Lin, H.; Bondarenko, P. V. Metabolic markers associated with high mannose glycan levels of therapeutic recombinant monoclonal antibodies, J Biotechnol 2015, 203, 22-31. http://www.sciencedirect.com/science/article/pii/S0168165615000966?via%3Dihub

Bondarenko, P. V.; Second, T. P.; Zabrouskov, V.; Makarov, A. A.; Zhang, Z. Mass measurement and top-down HPLC/MS analysis of intact monoclonal antibodies on a hybrid linear quadrupole ion trap-Orbitrap mass spectrometer. J. Am. Soc. Mass Spectrom. 2009, 20 (8), 1415-1424. https://www.sciencedirect.com/science/article/pii/S104403050900227X?via%3Dihub

Dillon, T. M.; Speed-Ricci, M.; Vezina, C.; Flynn, G. C.; Liu, Y. D.; Rehder, D. S.; Plant, M.; Henkle, B.; Li, Y.; Varnum, B.; Wypych, J.; Balland, A.; Bondarenko, P. V. Structural and functional characterization of disulfide isoforms of the human IgG2 subclass, Chem. 2008, 283, 16206-16215. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259628/

Bondarenko, P. V.; Chelius, D.; Shaler, T. A. Identification and relative quantitation of protein mixtures by enzymatic digestion followed by capillary reversed-phase liquid chromatography-tandem mass spectrometry. Anal. Chem. 2002, 74 (18), 4741-4749. https://pubs.acs.org/doi/10.1021/ac0256991

Education

Ph.D., Analytical Chemistry, Texas A&M University- College Station, Texas
M.S., Electrical and Mechanical Engineering, Moscow Engineering Physics Institute, USSR