Amy He

Amy He is Vice President of Process Development at Bionova Scientific.

Prior to joining Bionova, Amy spent 10 years at Abbvie/Abbott Labs as a Principal Research Scientist. She also held scientist roles at Facet Biotech, Protein Design Labs (PDL) Pharma, Affymetrix, Abgenix and Chiron Corporation.

Amy’s early work focused on Target Discovery and Target Validation for drug discovery. Over the past several years, she has focused on developing high-yield production cell lines in NS0 and CHO host cells for GMP manufacturing of clinical and commercial biologics, including mAbs, bi-specific mAbs and non-mAbs proteins. She established best practices to shorten the timeline and reduce labor by evaluating, developing and incorporating new technologies including vector optimization, Octet and AlphaLISA for HT quantitation, Fed-batch Spin Tube/shake flask assay, CloneSelect Imager, ClonePix and FACS sorting. She is an inventor on the US patent for “Vectors and Host Cells Comprising A Modified SV40 Promoter for Protein Expression”.

Amy was also responsible for genetic characterization of cell lines and is highly proficient in identifying and characterizing complex RNA variants to ensure acceptable product quality. She authored and reviewed technical reports and relevant sections in regulatory filing documents for 10 INDs and 2 BLAs.

Amy earned her M.S. in Biochemistry and Biophysics at Iowa State University and her B.S.in Biochemistry at Peking University, China.