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Cgmp Recombinant Fix For Iv And Oral Hemophilia B Therapy, William H. Velander Principal Investigator, Abramson Stephan Lead Investigator, Cooper Julian Lead Investigator, William Dernell Key Person, Mark Manning Lead Investigator, Michael Meagher Lead Investigator, Paul Mohanan Lead Investigator, Timothy Nichols Lead Investigator, Todd Swaanson Key Person, Kevin E. Van Cott
Cgmp Recombinant Fix For Iv And Oral Hemophilia B Therapy, William H. Velander Principal Investigator, Abramson Stephan Lead Investigator, Cooper Julian Lead Investigator, William Dernell Key Person, Mark Manning Lead Investigator, Michael Meagher Lead Investigator, Paul Mohanan Lead Investigator, Timothy Nichols Lead Investigator, Todd Swaanson Key Person, Kevin E. Van Cott
Department of Chemical and Biomolecular Engineering: Funded Proposals
Three specific aims are proposed: Specific Aim # 1. Process engineer and scale-up the recovery and purification of transgenic recombinant human Factor IX. The University of Nebraska-Lincoln Biological Process Development Facility will complete process development and scale-up, and produce clinical grade materials for preclinical studies. The endpoint is a proposed final product specification to help facilitate transfer to current Good Manufacturing Practices compliant production of clinical grade material to support an Investigational New Drug filing with the United States Food and Drug Administration (FDA) leading to clinical trials. Specific Aim #2. Characterize and formulate transgenic recombinant human Factor IX for …