Rui Nian

Professor at Qingdao Institute of Bioenergy and Bioprocess Technology, Chinese Academy of Sciences
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Contact Information
us****@****om
(386) 825-5501
Location
Qingdao, Shandong, China, CN

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Experience

    • Professor
      • Oct 2015 - Present

      Managed a group engaging in biomaterial research Managed a group engaging in biomaterial research

    • Research Scientist
      • Jun 2012 - Sep 2015

      - Managed research projects about development of novel technology for monoclonal antibody purification. • Developed new non-chromatographic method for IgG purification. Protein recovery and contaminant removal (HCP, residual DNA) were equivalent or higher compared to Protein A chromatography. • Developed highly effective non-affinity IgG purification technique by exploiting the new features of current chromatographic resins. Achieved 99.9% HCP removal from cell culture supernatant with one-step purification. • Investigated and optimized current IgG recovery techniques to achieve 2-steps purification which can be an alternative to current 3 or 4 steps antibody processing used for normal biopharmaceuticals. • Evaluated new resins (Protein A, ion exchangers, hydroxyapatite etc.) from different vendors. Accumulated valuable data regarding the performance of various newly developed innovative resins.

    • Lead Scientist, Downstream Processing
      • Jul 2010 - May 2012

      - Development of manufacturing processes for therapeutic monoclonal antibodies (mAbs). • Conducted lab-scale research to investigate and optimize the necessary purification approaches involved in mAb purification, including protein A chromatography, ion exchange and hydrophobic interaction chromatography. Incorporated quality by design (QbD) into process development to ensure pharmaceutical quality and design of experiments (DoE) was used to identify the key and critical operational parameters for each chromatographic steps and finally established the ‘Process Design Space’ which can deliver product with optimal and reproducible quality and yields.• Conducted the scale-up of downstream purification process from the lab-scale to pilot-scale to realize the commercial application of the technology developed in the laboratory to industrial application. Solved many scale-up issues regarding the equipment, operation, process design/redesign, usage of consumables etc.• Conducted pilot-scale purification (from up to 200 L cell harvest) in a GLP environment. Integrated and streamlined the biopharm purification processes, including depth filtration, several chromatographic steps, virus filtration, UF/DF and sterile filtration.• Conducted trouble-free technology transfer from R&D site in Singapore to the commercial production site in China, ensuring the streamlined technology transfer and successful scale-up in production site. • Developed/proposed several novel chromatographic and non-chromatographic methods for mAb purification, e.g. two-step purification platform based on protein A chromatography and ceramic hydroxyapatite (CHT) as well as crystallization and liquid/liquid phase separation of mAb. - Inspected and audited laboratory protocols, data, reports to assure compliance with current GLP regulations, applicable SOPs, and other requests. - Performed training of new personnel and trainee.

    • Postdoctoral Fellow
      • Jan 2010 - Jun 2010

    • Senior Researcher
      • Aug 2008 - Dec 2009

Education

  • National University of Singapore
    Doctor of Philosophy (PhD), Chemical and Biomolecular Engineering
    2003 - 2008
  • Tianjin University
    Bachelor's degree, Chemical Engineering
    1999 - 2003

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