Xuhua Duan

Knowledgeable with a solid background in ICH guidelines, quality control of therapeutic proteins and vaccine products. Skilled in development, validation, verification, and transfer of Bioassay methods. Successfully led initiatives that streamlined processes and improved departmental efficiency. Demonstrated leadership and problem-solving skills in high-pressure environments.

• Member of the Blood Products Branch of the China Vaccine Industry Association
• Youth Committee member of the Drug Analysis Professional Committee of the Chinese Pharmaceutical Association
• Editorial board member of 'Chinese Pharmaceutical Industry Journal' and 'International Journal of Biologics'

• Date of Birth: 12/06/81
• Gender: Female
• Nationality: P.R. China

• Training on Peptide and Biologic Standards, USP, 03/01/16
• Training on Bioassay Design, Development, and Validation, USP, 05/01/16
• Training on Method Development and Validation for Biologics, USP, 05/01/19
• Training on Quality Control of COVID-19 Inactivated Vaccine, NIFDC, 02/01/21
• Training on USP Analytical Data-Interpretation and Treatment, USP, 05/01/23

• Establishment and validation of a reporter gene assay for antibody-dependent cellular phagocytosis of IgG2 type anti-EGFR monoclonal antibody based on DOE design., Zhao Q, Zhou Q, Wang M, Li T, Wang C, Duan X#, Shao H., Chinese Journal of Biological Products, 2024, 37, 07, 859-865, (Corresponding author)
• Development of anti-CD80 drug binding activity method based on SPR technology., Dong S, Shi Z, Duan X#, Shao H#, Chen G., China Pharmacist, 2023, 26, 10, 74-81, (#: Co-corresponding author)
• Normalized application of four-parameter logistic model in bioassay based on Microsoft Excel., Duan X, Wang M, Ling J, Shao H, Chen G., Chinese Journal of Biologics, 2021, 34, 02, 202-206+212
• Development of Statistical Analysis Method for Biological Activity Determination of Human Coagulation Factor VIII., Shi Z, Wang M, Duan X#, Shao H#, Chen G., Chinese Pharmaceutical Journal, 2022, 57, 07, 573-577, (#: Co-corresponding author)
• Development and Application of the Method (Chromogenic Substrate Assay) for Biological Activity Determination of Human Coagulation Factor VIII., Shi Z, Wang M, Duan X#, Shao H#, Chen G., China Pharmacist, 2022, 25, 07, 1296-1301, (#: Co-corresponding author)
• Analysis of the guidelines for the validation of biological activity/potency determination methods of biological products., Wang M, Chen G, Zhao Y, Shao H, Duan X#., Chinese Drug Standards, 2022, 23, 03, 241-245, (Corresponding author)
• Establishment of a pseudovirus neutralization assay based on SARS-CoV-2 S protein incorporated into lentiviral particles., Wang S, Liu L, Wang C, Wang Z, Duan X, Chen G, Zhou H, Shao H., Biosafety and Health, 2022, Feb, 4, 1, 38-44
• Development and validation of a novel luciferase reporter gene assay to detect pyrogen., Wang C, Wang M, Liu L, Li G, Wu Y, Wang Z, Duan X, Shao H, Chen G., Biologicals, 2022, Jun, 77, 16-23
• A rapid detection method for virus titer of live attenuated varicella vaccine using PMAxx-qPCR., Duan X, Cai Y, Wang Z, Shi Z, Tian Q, Wang M, Shao H, Zhou Q, Zhao Q, Chen G., 2024105975054
• A plasmid and stable cell line for reflecting immune synapse-related signal proteins using a luciferase complementary system and its application., Wang S, Shao H, Chen G, Wang C, Wang Z, Duan X, Zheng L., ZL202111328033.52
• Inspection and practice of recombinant monoclonal antibody products for human use., Fudan University Press, 2022, Jun