Wenchao Liu
Vice President of CMC @ Phrontline Biopharma
About
Highly motivated and coaching style manager and scientist with over 10 years of experience in manufacturing process development of therapeutical antibody drug conjugates (ADC) and monoclonal antibodies. Accomplished with IND clearance of 6 ADCs from both of NMPA and FDA and BLA approval of 1 mAb in China. Expertise in implementation of QbD and DoE in process development, process characterization and validation. Solid knowledge in the design of ADC molecules, including the selection of antibody, payload, linker as well as conjugation technologies. Plus with 2 years of practical experience in management of GMP manufacturing for drug product.
China
Shanghai
Biotechnology
Bispecific Antibody, CMC, IND, BLA, Antibody drug conjugate, Quality by Design, Design of Experiments (DOE), Bioprocess, Protein Purification, English, Process characterization, Biotechnology, Leadership, Production Process Development, Process performance qualification, GlycoConnect
Experience
Vice President of CMC
Phrontline Biopharma
China
In charge of the CMC development of Bispecific ADC
Director & Principal Scientist in Bioprocess
Shanghai Miracogen Inc
Shanghai, China
Lead and responsible for the manufacturing process development, pilot production, tech transfer and GMP manufacturing, process characterization and validation (PPQ) for ADC drug substance; Lead and responsible for the purification process development, process characterization and validation for monoclonal antibodies; Oversee and manage CRO/CDMO for production cell line development, cell culture process development, tech transfer, pilot and GMP manufacturing, process characterization and process validation (PPQ) for mAbs; Author and reviewer of IND and NDA dossiers (process sections) for application in China and US.
Senior Scientist & Associate Director in Bioprocess
Shanghai Miracogen Inc
Shanghai, China
Lead and responsible for the manufacturing process development, pilot production, tech transfer and GMP manufacturing for ADC drug substance; Lead and responsible for the purification process development for monoclonal antibodies; Oversee and manage CRO/CDMO for production cell line development, cell culture process development, tech transfer, pilot and GMP manufacturing of mAbs; Develope a robust and efficient manufacturing process for a site-specific ADC in 6month, using GlycoConnect technology licensed from Synaffix; Author and reviewer of IND dossiers (process sections) for application in China and US.
Senior Scientist & Manager, Bioprocess
Shanghai Miracogen Inc
Shanghai, China
Lead and responsible for the manufacturing process development, pilot production, tech transfer and GMP manufacturing for ADC drug substance; Lead and responsible for the purification process development for monoclonal antibodies; Oversee and manage CRO/CDMO for production cell line development, cell culture process development, tech transfer, pilot and GMP manufacturing of mAbs; Author and reviewer of IND dossiers (process sections) for application in China and US.
Senior Biomedical Engineer & Group Leader
Shanghai Miracogen Inc
Shanghai, China
Lead and responsible for the manufacturing process development, pilot production, tech transfer and GMP manufacturing for ADC drug substance; Author and reviewer of IND dossiers (process sections).
Biomedical Engineer & Group Leader
Shanghai Miracogen Inc
Shanghai, China
Lead and responsible for the manufacturing process development, pilot production, tech transfer and GMP manufacturing for ADC drug substance Author and reviewer of IND dossiers (process sections)
Associate Supervisor
Hengrui Pharma
Jiangsu, China
Assist the Production Chief in the running and implementation of GMP manufacturing activities in Oral tablets, Oral liquid and Soft capsule production lines.
Education
The Hong Kong Polytechnic University
Structural Biology
Peking Union Medical College
Microbiological and biochemical pharmaceutical science
Wuhan University
Pharmaceutical Science
Wenchao Liu's Contact Information
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