Liming Shi

Liming Shi has 22 years’ biologics experience in US biopharmaceutical industry. He previously worked at Genentech, Amgen, Eli Lilly and Pfizer. Liming specializes in bioassay development, qualification and validation; tech transfer; CRO management; quantitative assay performance management with trending analysis and deviation investigation. He has profound expertise in all kinds of analytical methods in biologics development. In his 22-year overseas career, he first created qPCR technology platform for virus removal testing in mAb purification process for the first time in the world when he was at Genentech. Following new USP chapters of 1032,1033,1034, he combined new USP concepts with statistical tools in biological activity testing and first time established new system suitability and sample acceptance criteria based on accumulated historical data in US when he was at Pfizer. His unique background combines proven experience in both project and team management; thorough expertise in biostatistics, DOE, and QbD; all kinds of analytical technology. His deep understanding of cGMP/cGLP; FDA/NMPA/EMA, ICH regulatory guidance; USP/ChP/EP chapters; his strong CMC and analytical experience provided critical support in numerous IND and BLA submissions. Liming joined CMAB Biopharma (Suzhou, China) in August 2018 and Transcenta Ltd. (Hangzhou, China) in December 2019. Now he is VP in charge of Analytical Science, Quality Control and Product & Process Development Operation. Liming holds two Master degree of M.A.; M.Sc.; and one ADMET certificate.