Mr. Fallentine serves as Director of Product and Process Development. He has held director level and senior engineering in both start-up, Fortune 500, and biosimilar companies and has more than 20 years of experience in the management of biologics, process development, process engineering, CMC, and manufacturing operations. Mr. Fallentine possesses significant expertise in scale-up and reactor characterization and development of large-scale cell culture processes for clinical manufacture of monoclonal antibodies and fusion proteins. He has managed multiple cell culture technology transfers conducted at external CMO’s and played a critical role in the development of two commercially approved drugs (Kogenate, Bexxar).
Mr Fallentine has also served as Engineering Lead for three clinical monoclonal antibody programs, BDS Lead for a pre-commercial biosimilar program, BDS Lead for a late-stage biosimilar program, and Process Engineering lead for a fusion protein program. Mr. Fallentine received a B.S. in Microbiology and Molecular Genetics from the University of California, Los Angeles.