Yung-Hsiang Kao

Principal Scientist, Process Development

POSTDOC MENTOR

"By focusing most heavily on proteins that respond to biological stimuli, transmit essential signals, or convert signals into function, we believe there is an opportunity to discover novel biology and impact the lives or patients with debilitating diseases."

• 18
  years at Genentech
• 14
  publications (2010-12)

I joined Genentech in 1995. as a post-doctoral fellow to study glycosylated protein and peptide using nuclear magnetic resonance (NMR) spectroscopy. I also began to work on NMR applications for supporting biopharmaceutical product development.

After completing my post-doctoral research, I took a Scientist position at Genentech. My group, currently including an NMR lab and a protein characterization lab, provides analytical supports for product characterization, assay development and validation, process development, process validation, and production troubleshooting.

• My Focus

  My lab is within Protein Analytical Chemistry, part of US Biologics Technical Development. The main focus of my lab is to provide analytical support for product characterization. Understanding structure-function relationship in our molecules is the main focus of my lab. Antibodies and other protein based biopharmaceutical products are heterogeneous because they typically contain multiple post-translational modifications.

  Our job is to determine what modifications exist in our products and what impact these modifications have on the products. We use multiple analytical tools, including chromatography, electrophoresis, and mass spectrometry, to help us identify product variants due to different modifications. Once product variants are identified, we often need to enrich these minor species present in the product for further characterization and determine their biological activities.

• Publications

  • Asparagine deamidation dependence on buffer type, pH, and temperature

    Journal of Pharmaceutical Sciences, 2013, ISSN: 0022-3549

    Pace, Amanda L; Wong, Rita L; Zhang, Yonghua Taylor; Kao, Yung-Hsiang; Wang, Y John

     View on PubMed

  • Identification of a single base-pair mutation of TAA (Stop codon) → GAA (Glu) that causes light chain extension in a CHO cell derived IgG1

    mAbs, 2012, ISSN: 1942-0862

    Zhang, Taylor; Huang, Yungfu; Chamberlain, Scott; Romeo, Tony; Shimoni, Judith Zhu; Hewitt, Daniel; Zhu, Mary; Katta, Viswanatham; Mauger, Brad; Kao, Yung-Hsiang

     View on PubMed

  • Quantitation and characterization of process impurities and extractables in protein-containing solutions using proton NMR as a general tool

    Biotechnology Progress, 2012, ISSN: 1520-6033

    Skidmore, Ken; Hewitt, Daniel; Kao, Yung-Hsiang

     View on PubMed

  • Identification and Characterization of Buried Unpaired Cysteines in a Recombinant Monoclonal IgG1 Antibody

    Analytical Chemistry, 2012, ISSN: 0003-2700

    Zhang, Taylor; Zhang, Jennifer; Hewitt, Daniel; Ben Tran; Gao, Xiaoying; Qiu, Zhihua Julia; Tejada, Max; Gazzano-Santoro, Helene; Kao, Yung-Hsiang

     View on PubMed

  • On-line characterization of monoclonal antibody variants by liquid chromatography-mass spectrometry operating in a two-dimensional format.

    Analytical Biochemistry, 2 Aug 2011, ISSN: 1096-0309.

    Alvarez, Melissa; Tremintin, Guillaume; Wang, Jennifer; Eng, Marian; Kao, Yung Hsiang; Jeong, Justin; Ling, Victor T; Borisov, Oleg V

     View on PubMed

  • Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80.

    Journal of Chromatography A, 2011, ISSN: 0021-9673

    Hewitt, D.; Alvarez, M.; Robinson, K.; Ji, J.; Wang, Y.J.; Kao, Y.H.; Zhang, T.

  • Ultra-High-Pressure LC (UHPLC) for therapeutic protein characterization.

    American Pharmaceutical Review, 2011, ISSN: 1099-8012

    Jeong, J.; Zhang, T.; Zhang, J.; Kao, Y.H.

  • Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80.

    Journal of Chromatography A, 2010, ISSN: 1873-3778

    Hewitt, D.; Alvarez, M.; Robinson, K.; Ji, J.; Wang, Y.J.; Kao, Y.H.; Zhang, T.

  • Charge variants in IgG1: Isolation, characterization, in vitro binding properties and pharmacokinetics in rats.

    mAbs, 2010, ISSN: 1942-0870

    Khawli, L.; Goswami, S.; Hutchinson, R.; Kwong, Z.; Yang, J.; Wang, X.; Yao, Z.; Sreedhara, A.; Cano, T.; Tesar, D.; Nijem, I.; Allison, D.; Wong, P.-Y.; Kao, Y.-H.; Quan, C.; Joshi, A.; Harris, R.; Motchnik, P.

  • Mechanism of Antibody Reduction in Cell Culture Production Processes.

    Biotechnology and Bioengineering, 2010, ISSN: 1097-0290

    Kao, Y.; Hewitt, D.; Trexler-Schmidt, M.; Laird, M.

  • SEC Assay for Polyvinylsulfonic Impurities in 2-(N-Morpholino) ethanesulfonic Acid Using a Charged Aerosol Detector.

    Chromatographia, 2010, ISSN: 0009-5893

    Zhang, T.; Hewitt, D.; Kao, Y.

  • Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing.

    Biotechnology & Bioengineering, 2010, ISSN: 1097-0290

    Trexler-Schmidt, M.; Sargis, S.; Chiu, J.; Sze-Khoo, S.; Mun, M.; Kao, Y.; Laird, M.

  • Small molecule clearance in ultrafiltration/diafiltration in relation to protein interactions: Study of citrate binding to a Fab.

    Biotechnology & Bioeningeering, 2009, ISSN: 1097-0290

    Harinarayan, C.; Skidmore, K.; Kao, Y.; Zydney, A.L.; van Reis, R.

  • Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection.

    Journal of Chromatography A, 2008, ISSN: 0021-9673

    Hewitt, D.; Zhang, T.; Kao, Y.H.

• Education
  • Penn State University, Ph.D. – 1994
  • Tsing Hua University, B.S. – 1986