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Experienced scientific researcher with a wide-ranging skill set including a strong biochemistry and analytical chemistry background in addition to broad expertise in FDA regulation.
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- Review of Chemistry, Manufacturing and Control (CMC) aspects of original BLAs, supplements, Annual Reports and INDs of various Biologics products submitted to the Office of Blood Research and Review
- Writing of memos covering review of process and viral clearance validation, stability, bioburden, sterility, extractable/leachables and other manufacturing processes impacting product quality, safety, potency and efficacy in a timely manner to meet deadlines.
- Participation in meetings (Pre-IND, pre-BLA and other) with sponsor and preparing written responses to sponsor questions pertaining to CMC issues.
- Conducted research involving understanding neutralizing antibodies against Hepatitis C virus
- Developed a luciferase-based binding assay to understand viral antigen, host-cell receptor, and antibody interactions for vaccine design and as early stage potency assay.
- Presented seminars relating to research results and regulatory topics to Division of Hematology
- Synthesized peptide analogs containing spectroscopic probes for protein kinase studies.
- Conducted research to elucidate the processes involved in neurodegenerative and protein aggregation diseases.
- Studies focused on interactions of various proteins involved in the cellular process of ER-associated degradation (ERAD) and ubiquitin-proteasome protein degradation pathways.
- Secondary duties of this position included mentoring graduate students and providing training and guidance to technicians in the laboratory.
- Conducted structural and function studies of membrane proteins.
- Research involved preparative scale protein expression using baculovirus system and preparative scale purification using various methods such as affinity, ion-exchange and size exclusion.
- Studies also included performing crystallization trials using microbatch and vapor diffusion methods.
- Thesis/ Dissertation: Studies focused on combining crystallographic techniques and kinetic analysis of substrate and inhibitor complexes with native and mutant Cyclooxygenases in order to understand substrate utilization and drug/protein interactions.
- Studies resulted in two first author publications in the Journal of Biological Chemistry.
- Research included DNA cloning, site-directed mutagenesis, protein expression in various cells lines including bacteria, insect and mammalian cells, protein purification, thin layer chromatography, protein crystallization and structure determination.
- Studies focused on transcription, purification and crystallization of large catalytic RNAs to understand the mechanism of catalytic RNAs.
- Method development and validation of analytical HPLC methods for various drug formulations containing multiple drug components.
- Responsible for following GLP and GMP protocols.
- Performed raw materials testing according to USP protocols.
- Performed USP dissolution assays in combination with quantification of time-released drugs formulations using HPLC methods.
- Performed validation of HPLC methods in compliance with GLP and GMP.
- Synthesis, purification, and characterization of monomeric and polymeric materials at Wright Laboratories/Materials Directorate at Wright Patterson Air Force Base.
Michigan State University - East Lansing, MI
- Advisors: William L. Smith and R. Michael Garavito
Wright State University - Dayton, OH
- Double Bachelors degree in Biology and Chemistry
Claire, C. A., Rieke, C. J., Garavito, R. M., and Smith, W. L. Crystal structure of arachidonic acid bound to a mutant of Prostaglandin Endoperoxide Synthase-1 that forms predominantly 11-HPETE. J. Biol. Chem. (2004), 279: 42429-35.
Claire, C. A, Kozak, K. R, Marnett, L. J., Smith, W. L., and Garavito, R. M. Structural basis of enantioselective inhibition of COX-1 by (S)--substituted indomethacin ethanolamides. J. Biol. Chem. (2007), 282: 28096-28105.
Lim, P.J., Danner, R., Liang, J., Doong H., Claire, C., Srinivasan D., Rothenberg, C., Wang, H., Ye, Y., Fang, S., and Monteiro, M.J. Ubiquilin and p97/VCP bind Erasin, forming a complex involved in ERAD. J. Cell Biol. (2009), 187(2): 201-17.
Duan, H., Kachko, A., Zhong, L., Struble, Evi., Pandey S., Yan, H., Claire, C., Virata-Theimer, M.L., Deng, L., Zhao, Z., Major, M., Feinstone, S., & Zhang, P. Amino Acid Residue-Specific Neutralization and Non-Neutralization of Hepatitis C Virus by Monoclonal Antibodies to the E2 Protein (2012) J. Virology 86(23): 12686-94
Deng, L., Zhong, L., Struble, E., Ma, L., Claire, C., Yan, H., Virata-Theimer, M.L., Zhao, Z., Feinstone, S., Alter, H., & Zhang, P. Structural Evidence for a bifurcated mode of action in the antibody-mediated neutralization of hepatitis C virus (2013) Proc Natl Acad Sci USA 110(18): 7418-22.
Claire, C., Zhong, L., Deng, L., Duan, Hongying, D., Zhong, Z., Ma, L., Liu, Peter., Struble, E., Yan, H., Feinstone, S., and Zhang, P. A View of the CD81-E2 Interface at the Binding Site of a Neutralizing Antibody against Hepatitis C Virus (in preparation 2013)
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School Attended
- Michigan State University
- Wright State University
Job Titles Held:
- Staff Fellow
- Undergraduate Research Assistant
- Postdoctoral Fellow
- Postdoctoral Research Associate
- Graduate Research Assistant
- Graduate Research Assistant
- Analytical Chemist
- Analytical Chemist
- Research Assistant
Degrees
- Ph.D
- B.S
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