Page 38 - Gates-AnnualReport-2018

GATES BIOMANUFACTURING FACILITY
2018 Gates Biomanufacturing Facility staff at a holiday get-together: (BACK ROW, left to right) Matthew Seefeldt, Timothy Gardner, Krutika Patel, Jessica Freeman, Deepa Vadakkan, Christopher Baclasky, Russell Marians, Branden Salinas (MIDDLE ROW, left to right) Mitchell Fraller, Bertina Minjares, Saundra Jernberg, Sonja Giguere, Paul Lemaire, Emily Yuan, Matthew Brenton (FRONT ROW, left to right) David Hahn, Rebecca Mallo, Caylee Martens, Kaela Siahpush, Aashrit Donthi, Christopher Garbe, Ryan Crisman (Not Pictured: Kevin Ash, Sarah Carter, Christopher Freedman, Graciela Gamez, Roger Giller, Jordan Krause, Felicia Lanzarone, Sadhna Mehra, Jackie Nelson, Thomas Street)
2018 was a pivotal year at the Gates Biomanufacturing Facility (GBF) as we produced our first clinical-grade material for use in a Phase 1 multiple myeloma CAR-T cell clinical trial. This is a major milestone for a Good Manufacturing Practice (GMP) facility and positions the GBF to compete with the top echelon of universities manufacturing products for university-sponsored clinical trials. The GBF’s ability to produce materials for clinical trials is the result of significant effort by our team to build and implement a strong quality management system that two third-party quality audits
have now reviewed and approved. We now have a top-tier facility combined with an experienced leadership team that understands the intricacies of doing clinical trials in leading- edge cell therapies, as well as more traditional protein biologics.
With our first Phase 1 GMP run in cell therapy behind us, we began the technology transfer process for production of materials for a CD19 CAR-T trial, which will be the first cell therapyclinicaltrialsponsoredbytheCUSchoolofMedicine
38 Gates Center for Regenerative Medicine