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    Barrett Fallentine

    Director - BioPharma Consultant - CMC - Process Development

    Barrett Fallentine is a seasoned cell culture process engineer with 22+ years of industry experience in biologics, CMC, and process/manufacturing sciences/operations.

    Currently serving as the Director of Product and Process Development at Pharmatech Associates, Inc., Barrett has significant expertise in managing upstream BDS CMC at external GMP Clinical Manufacturing Sites.

    His vast experience includes extensive knowledge in scale-up, reactor characterization, and development of large-scale cell culture processes for clinical manufacture of monoclonal antibodies and fusion proteins.

    Barrett has successfully managed numerous cell culture and cell therapy technology transfers, as well as played critical roles in developing commercially approved drugs like Kogenate and Bexxar.

    As an Engineering Lead, he has been instrumental in three clinical monoclonal antibody programs and has taken on leadership roles in various biosimilar and fusion protein programs.

    His skill set includes process development, process engineering through DOE, scale-up and scale-down expertise, process validation implementation following ICH Q8/9 and FDA's PV guidelines, BDS technology transfer, BLA CMC development and submission support, as well as CMO management and technical oversight.

    Barrett Fallentine pursued his Bachelor of Sciences at the University of California, Los Angeles, and furthered his education with a certificate program at the prestigious Massachusetts Institute of Technology.

    Barrett Fallentine
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    Location

    San Francisco, California, United States