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Cell & Gene Therapy Manufacturing & Commercialization US

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Delivered as a Hybrid Event
September 27-30, 2022Boston Convention and Exhibition Center

Basak Clements
Associate Director, Material Sciences, Biotherapeutics Development and Supply at Janssen

Profile

Basak works at Janssen (Johnson & Johnson) BioTherapeutics Development & Supply, Material Sciences group as an Associate Director. In her capacity, she is responsible for leading efforts on raw material risk assessments and control strategies, understanding and characterization of raw materials in CMC development, and supplier/CMO collaborations supporting the materials used in Janssen’s portfolio of monoclonal antibodies, cell and gene therapies and vaccines. Prior to joining Johnson & Johnson, Basak was a Senior Manager in External Supply, Raw Materials and Devices group and a Senior Scientist in Process Development, Materials Science group at Amgen in Thousand Oaks, CA. Leading up to her industry career Basak conducted post-doctoral research at New Jersey Center for Biomaterials at Rutgers University working on a number of regenerative medicine projects. She holds B.Sc., M.Sc. and Ph.D. degrees in Chemical Engineering and Pharmacy & Pharmaceutical Sciences.

Agenda Sessions

  • Cell and Gene Therapy Critical Starting Material – Further Discussion on Plasmids to Establish Release Specifications and Using a Risk-Based Approach to Manage Supply

    4:00pm