Over 30 years of industrial and laboratory research experience in cell culture/fermentation with extensive hands-on and supervisory experience in process development and scale-up. Complete and comprehensive experience in phase 1 through phase 3 clinical productions and pre-BLA CMC documentations.Specialties: 1) Gene therapy product, therapeutic protein, plasmid DNA vaccine process development and productions.2) Perfusion, Fed-batch, and Batch cell culture processes.3) Mammalian cell (human cell lines, dog cell lines, hybridomas), microbial (bacteria, yeast, filamentous fungi), and insect-cell/baculovirus fermentations.4) Bioreactor process design and scale-up.5) Management of group/team (BS, MS, PhD) and projects.6) Management of CMO's.7) cGMP manufacture and FDA filing (CMC) for various phases of clinical productions.8) GLP study - production of qualified pre-clinical material and qualification of cell-based assay for GLP study.
Listed skills include Purification, Cell, Gmp, Cell Culture, and 8 others.