Huimin (Cynthia) Li, M.S.
Before joining APL in 2018 Cynthia spent almost 23 years at Amgen. During the 23 years at Amgen, she managed and executed numerous bioanalytical testing projects for molecule assessment of therapeutic protein candidates, protein high-order structure characterization, product comparability and similarity assessments. She has extensive hands-on experiences with Fourier-transform infrared spectroscopy (FTIR), Raman spectroscopy (Raman), Differential scanning calorimetry (DSC), Circular dichroism (CD), fluorescence spectroscopies (FL), Dynamic light scattering (DLS), Capillary electrophoresis (CE), Amino Acid analysis (AAA) and HPLC. She is familiar with CMC filing and authored various sections of filing documents for several biosimilar programs.
Prior to working at Amgen, Cynthia was a research scientist at Genemedicine Inc designing and constructing gene delivery formulations, characterizing DNA-formulation and DNA-protein complexes by DLS, ITC, DSC, electron microscopy, FTIR, CD, UV-VIS and fluorescence spectroscopies. She received her M.S. in Chemistry in 1987 from Peking University and M.S. in Biochemistry in 1992 from University of Missouri-Kansas City.
Cynthia has authored 27 scientific publications, listed here, including 25 directly related to biotechnology and pharmaceutical applications.
N. Seo, A. Polozova, M. Zhang, Z. Yates, S. Cao, Huimin Li, S. Kuhns, G. Maher, H. J. McBride & J. Liu. (2018) Analytical and function similarity of Amgen biosimilar ABP 215 to bevacizumab, MABS,
F.W. Jacobsen, R. Stevenson, Cynthia H. Li, Salimi-Moosavi, L. Liu, J. Wen, Q. Luo, K. Daris, L. Buck, S. Miller, S.Y. Ho, W. Wang, Q. Chen, K. Walker, J. Wypych, L. Narhi, K. Gunasekaran (2017) Engineering an IgG Scaffold Lacking Effector Function with Optimized Developability, J. Biol. Chem. 292(5), 1865-1875.
J. Liu, T. Eris, Cynthia Li, Shawn Cao, Scott Kuhns (2016) Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab, BioDrugs DOI 10.1007/s40259-016-0184-3
Y. Jiang, Cynthia Li, J. Li, J. P. Gabrielson and J. Wen (2015) Technical Decision-Making with Higher Order Structure Data: Higher Order Structure Characterization During Protein Therapeutic Candidate Screening, Journal of Pharmaceutical Sciences, 104, 1533–1538
B. M. Teska, Cynthia Li, B. C. Winn, K. K. Arthur, Y. Jiang, J. P. Gabrielson (2013) Comparison of quantitative spectral similarity analysis methods for protein higher-order structure confirmation, Analytical Biochemistry, 434, 153–165
L. O. Narhi, Cynthia H. Li, R. Ramachader, J. Svitel and Y. Jiang (2013) “Optical Spectroscopic Methods for the Analysis of Biological Macromolecules”, Molecular Biophysics for the Life Sciences, Springer, 33-90
Y. Jiang, Cynthia Li, and J. Gabrielson, (2013) “Qualification of Biophysical Methods for the Analysis of Protein Therapeutics”, Biophysics for Therapeutic Protein Development, Springer, 99-126
L. Zhang, H. Tan, Cynthia Li, D. Catrone and J. Zhang (2012) Rapid Solubility Measurement for Recombinant Therapeutic Antibody in Monovalent Salt Solutions: Both Direct and Reverse Hofmiester Series Effects, Journal of Pharmaceutical Sciences, 101(3), 965-977
Y. Jiang, Cynthia Li, X. Nguyen, S. Wang, S. Muzammil, E. Towers and L. Narhi (2011) Qualification of FTIR spectroscopic method for protein secondary structural analysis, Journal of Pharmaceutical Sciences, 100(11), 4631-4642
Cynthia H. Li, X. Nguyen, L. Narhi, L. Chemmalil, E. Towers, S. Muzammil and Y. Jiang, Applications of Circular Dichroism for structural analysis of proteins: Qualification and limitations of the technique Journal of Pharmaceutical Sciences, 100(11), 4643-4654
Cynthia H. Li, L. O. Narhi, J. Wen, M. Dimitrova, Z. Q. Wen, J. Li, J. Pollastrini, X. Nguyen, T. Tsuruda and Y. Jiang (2012) The Effect of pH, temperature and salt on the stability of E. coli- and CHO-derived IgG1 Fc, Biochemistry, 51, 10056-10065
Cynthia H. Li and T. Li (2009) Application of Vibrational Spectroscopy to the Structural Characterization of Human Monoclonal Antibody and its Aggregations During Formulation Development, Current Pharmaceutical Biotechnology, 10, 391-399
Y. Jiang, Y. Samuel-Nashed, Cynthia Li, W. Liu, J. Pollastrini, D. Mallard, J. Davis and L. Narhi (2009) Tungsten-induced protein aggregation: Solution behavior, J Pharm Sci., 98(12), 4695–4710
R. Ramachander, Y. Jiang, Cynthia Li, T. Eris, M. Young, M. Dimitrova and L. Narhi (2008) Solid state fluorescence of lyophilized proteins, Analytical Biochemistry, 376, 2008, 173-182.
S. Krishnan, Eva Y. Chi, S. J. Wood, B. S. Kendrick, Cynthia Li, W. Garzon-Rodriguez, J. Wypych, T. W. Randolph, L. O. Narhi, A. L. Biere, M. Citron, J. F. Carpenter (2003) Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis, Biochemistry, 42(3), 829-837.
T. C. Boone, Huimin Li, M. B. Mann (2007) Methods for the treatment of thrombosis [Patent] Official Gazette of the United States Patent & Trademark Office Patents. Mar. 27 2007
T. C. Boone, Huimin Li, M. B. Mann (2003). DNA molecules encoding fibrinolytically active polypeptide [Patent] Official Gazette of the United States Patent & Trademark Office Patents. 1274(2). Sep. 9, 2003.
T. C. Boone, Huimin Li, M. B. Mann (2001) Fibronolytically active polypeptide [Patent] Official Gazette of the United States Patent & Trademark Office Patents. 1248(3). July 17, 2001.
Cynthia. H. Li, S. Steavenson, J. Wypych, A. L. Biere, M. Citron, L. Narhi (1999) Studies of the Interaction Between a-Synuclein and the Liposome, Protein Science 8, 454.
J.G. Duguid, Cynthia Li, M. Shi, M. Logan, A. Hector, A. Rolland, E. Tomlinson, J.T. Sparrow and L.C. Smith (1998) A Physicochemical Approach for Predicting the Effectiveness of Peptide-Based Gene Delivery Systems for Use in Plasmid-Based Gene Therapy, Biophys. J., 74, 2802-2814.
Huimin Li, C. Hanson, J. A. Fuchs, C. Woodward and G. J., Jr. Thomas (1993) Determination of the pKa Values of Active-Center Cysteines, Cysteines-32 and -35, in Escherichia coli Thioredoxin by Raman Spectroscopy, Biochemistry, 32, 5800-5808.
R. Tuma, S. Vohnik, Huimin Li, and G. J., Jr. Thomas (1993) Cysteine Conformation and Sulfhydryl Interactions in Proteins and Viruses. 3. Quantitative Measurement of the Raman S-H Band Intensity and Frequency, Biophys. J., 65, 1066-1072.
Huimin Li, C. J. Wurrey and G. J., Jr. Thomas (1992) Cysteine Conformation and Sulfhydryl Interactions in Proteins and Viruses. 2. Normal Coordinate Analysis of the Cysteine Side Chain in Model Compounds, J. Am. Chem. Soc., 114, 7463-7469.
Huimin Li and G. J., Jr. Thomas (1991) Cysteine Conformation and Sulfhydryl Interactions in Proteins and Viruses. 1. Correlation of the Raman S-H Band with Hydrogen Bonding and Intramolecular Geometry in Model Compounds, J. Am. Chem. Soc., 113, 456-462.