Xiaoyu Yang
Xiaoyu Yang
Principal Scientist
  • :(908) 740-6568

Bioprocess Development
Merck Research Laboratories


1993-2000   Post-Doc Harvard Medical School Immunology and Virology
1993 Ph.D. Washington State University Biochemistry and Biophysics
1985 M.S. Chinese Academy of Sciences, Beijing, China Biochemistry and Physiology
1982 B.S. Hainan University, Hainan, China Biology



Xiaoyu Yang, Ph.D. is a principal scientist inBioprocess Development, Merck Research Laboratories.Xiaoyu received a Ph.D in Biochemistry and Physics from Washington State University and later was trained in Harvard Medical School and Dana Farber Cancer Institute for postdoctoral studies in HIV virology.  Since joining Merck, Xiaoyuhas had extensive experience in protein purification and analytics for various biologic drugs.  He currently is a project leader in analytical development for mAbs, and has developed various analytical methods involved in extended characterization of antibodies and other proteins.  Xiaoyu also leads multiple analytical teams in generating critical data for BLA submissions.He has provided key technical expertise and support in solving drug substance and drug product related issues and challenges.

Research Interest

Biologics are a wide range of products such as vaccines, blood and blood components,, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins for treating different human diseases. My research interests include understanding and analysis of protein aggregation, post-translational modifications (glycosylation, oxidation, deamidation, and isomerization), structural stability in the biologics, such as therapeutic mAbs and insulins.  Research focus is development of the analytical methodologies including reverse phase chromatography, ion exchange chromatography, hydrophobic interaction chromatography, size exclusion chromatography on HPLC or UPLC, light scattering, CD, fluorescence and IR spectroscopy, and mass spectrometry to analyze biologic products during different stages of biologic production.

Professional Activities:

Honors and Awards

  • Level 3 shining performance award: glycan analysis
  • Schering PharmSci Excellence Award
  • Schering Level 3 shining performance award: recent patent granted
  • Schering Level 3 shining performance award: innovative work on RCA detection technology
  • Recipient of Harvard AIDS Training Grant Fellowship
  • Graduate Fellowship
  • Best Student Paper Award of Washington State University
  • Recipient of Best Student Award



  1. Xiaoyu Yang, Sunnie Myung Kim, Richard Ruzanski, Yuetian Chen, Daisy Richardson, Alexandre Ambrogelly, and Mohammed Shameem (2015) UltraFast High Throughput N-Glycan Analysis for Monoclonal Antibodies by MALDI mass spectrometry.  mAbs, in review.
  2. Alex Pavon, Xiaojuan Li, Steve Chico, Daisy Richardson, Huijuan Li, Mohammed Shameem, and Xiaoyu Yang* (2015) Fast characterization of antibody oxidation by a mixed mode chromatography. J. Chromatography A (in revision)

*corresponding author

  1. Giovanna Scapin, Xiaoyu Yang, Winifred W. Prosise, Mark McCoy, Paul Reichert, Ramesh Kashi, and Corey Strickland (2015) High resolution structure of Pembrolizumab, an IgG4 antibody approved for the treatment of melanoma.  Nature Structural Biology and Molecular Biology, on Press.
  2. Xiaoyu Yang, Fengqiang Wang, Ying Zhang, Larry Wang, Svetlana Antonenko, Shuli Zhang, Yi Wei Zhang, Mohammad Tabrizifard, Grigori Ermakov, Derek Wiswell, Maribel Beaumont, Liming Liu, Daisy Richardson, Mohammed Shameem and Alexandre Ambrogelly (2015)  Comprehensive Analysis of the Therapeutic IgG4 Antibody Keytruda:  Hinge Modification Blocks Half Molecule Exchange in vitro and in vivo,  J Pharm Sci, (Early view, and on Press)
  3. Xiaoyu Yang, Ying Zhang, Fengqiang Wang, Larry Wang, Daisy Richardson, Mohammed Shameem  and Alexandre Ambrogelly (2015) Analysis and Purification of IgG4 Bispecific Antibodies by a Mixed-Mode Chromatography.  Analytical Biochemistry 484, 173–179
  4. Xiaoyu Yang and Alex Ambrogelly (2014) Enlarging the repertoire of therapeutic monoclonal antibodies platforms: domesticating half molecule exchange to produce stable IgG4 and IgG1 bispecific antibodies. Curr Opin Biotechnol. , 30:225-229. (Review Article)
  5. Xiaodun Mou, Xiaoyu Yang *, Hong Li, Alexandre Ambrogelly, and  David J Pollard (2014) A high throughput ultra-performance size exclusion chromatography assay for the analysis of aggregates and fragments of monoclonal antibodies.  Pharm. Bioprocess, 2:141–156

*co-first author

  1. Peter Orth, Li Xiao, Lorraine D. Hernandez, Paul Reichert, Payal R. Sheth, Maribel Beaumont, Xiaoyu Yang, Nicholas Murgolo, Grigori Ermakov, Edward DiNunzio, Fred Racine, Jerzy Karczewski,  Susan Secore, Richard N. Ingram, Todd Mayhood, Corey Strickland and Alex G. Therien (2014) Mechanism of Action and Epitopes of Clostridium difficile Toxin B-neutralizing Antibody Bezlotoxumab Revealed by X-ray Crystallography. J Biol Chem. 289:18008-18021.
  2. Angela Mohs , Alexandre Ambrogelly , Xiaoyu Yang , Mark Haverick , Jason K. Cheung , Chakravarthy Narasimhan , and Mohammed Shameem (2014) Effect of Pegylation on Self-Association of IFN-α2b.  Mol. Pharmaceutics, 11: 158–163.
  3. Yang X, Xu W, Dukleska S, Benchaar S, Mengisen S, Antochshuk V, Cheung J, Mann L, Babadjanova Z, Rowand J, Gunawan R, McCampbell A, Beaumont M, Meininger D, Richardson D, Ambrogelly A.  (2013) Developability studies before initiation of process development: improving manufacturability of monoclonal antibodies. MAbs. 5:787-94.
  4. Yan-Hui Liu, , , David Wylie, Jia Zhao, Raymond Cure, Collette Cutler, Susan Cannon-Carlson, Xiaoyu Yang, Tattanahalli L. Nagabhushan, Birendra N. Pramanik (2011) Mass spectrometric characterization of the isoforms in Escherichia coli recombinant DNA-derived interferon alpha-2b.  Anal Biochem. , 408:105-117.
  5. Xiaoyu Yang, Shilpi Agarwala, Sundari Ravindran and Gary Vellekamp  (2008) Determination of particle heterogeneity and stability of recombinant adenovirus by analytical ultracentrifugation in CsCl gradients.  J Pharm Sci., 97(2):746-763.
  6. Goncalves JM, Silva F, Freitas-Vieira A, Santa-Marta M, Malho R, Yang X, Gabuzda D, Barbas C 3rd. (2002)  Functional neutralization of HIV-1 Vif protein by intracellular immunization inhibits reverse transcription and viral replication.
    J. Biol. Chem., 277, 32036-45.
  7. Yang X, Chen Y and Gabuzda D. (1999) ERK MAPK links cytokine signals to activation of latent HIV-1 infection by stimulating a cooperative interaction of AP-1 and NF-KB. J. Biol. Chem. 274, 27981-27988.
  8. Yang X and Gabuzda D. (1999) Regulation of human immunodeficiency virus type 1 infectivity by the ERK mitogen-activated protein kinase signaling pathway. J. Virol. 73, 3460-3466.
  9. Yang X and Gabuzda D. (1998) Mitogen-activated protein kinase phosphorylates and regulates the HIV-1 Vif protein. J. Biol. Chem. 273, 29879-29887.
  10. He J, Chen Y, Farzan M, Choe H, Ohagen A, Gartner S, Busciglio J, Yang X, Hofmann W, Newman W. Mackay C, Sodroski J, and Gabuzda D. (1997) CCR3 and CCR5 are co-receptors for HIV-1 infection of microglia. Nature 385, 645-649.
  11. Yang X, Goncalves J, and Gabuzda D. (1996) Phosphorylation of Vif and its role in HIV-1 replication. J. Biol. Chem. 271, 10121-10128.
  12. Goncalves J, Shi B, Yang X, and Gabuzda D. (1995) Biological activity of HIV-1 Vif requires membrane targeting by C-terminal basic domains. J. Virol 69, 7196 7204.
  13. Yang X, Daniell H, and McFadden BA. (1994) The complete nucleotide sequence and replication analysis of the plasmid pCB2.4 from the cyanobacterium Synechocystis 6803. Plasmid 31, 131-137.
  14. Yang X, Daniell H, and McFadden BA. (1994) In vitro replication of cyanobacterial plasmids from Synechocystis 6803. Plasmid 32, 195-207.
  15. Yang X and McFadden BA. (1993) A small plasmid pCA2.4 from the cyanobacterium Synechocystis 6803 encodes a Rep protein and replicates by a rolling circle mechanism. J. Bacteriol. 175, 3981-3991.
  16. Yang X, Daniell H, and McFadden BA. (1993) A facile method to study DNA synthesis in the cyanobacterium Synechocystis 6803. Curr. Microbiol. 29, 171-175.
  17. Yang X and Liu C. (1988) Relationship between chilling injury and adenylate metabolism in rice seedlings. Acta Phytophysiologica Sinica 14, 344-349.


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