The Gates Biomanufacturing Facility (GBF) is a partnership among the Gates Center, University of Colorado Anschutz Medical Campus, University of Colorado School of Medicine, Children’s Hospital Colorado, University of Colorado Health and the Gates Frontiers Fund.
Generous gifts from the private sector totaling $8.5 million covered renovation and equipment costs, and partner institutions below are each contributing toward operating costs.
The Gates Biomanufacturing Facility (GBF) held its Grand Opening on April 6, 2015. The GBF is operated by the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine.
Gates Biomanufacturing Facility Team
From Left to Right – Rebecca Vartuli, Kaela Siahpush, Russell Marians, Sadhna Mehra, Deepa Vadakkan, Renee Jesser, Mitchell Fraller, Bailey Leadford, Sonja Giguere, Heather Clark, Tim Gardner, David Hahn, Frances Brostrom, Paul Lemaire, Jackie Nelson, Matt Seefeldt, Juan Mantalvo, Carter Sarah, Bertina Minjares, Graciela Gamez, Felicia Lanzarone, Christopher Freedman, Jaclyn Valentine, Debbie Keenan, Jessica Freeman, Saundra Jernberg, Tom Street
Ryan Crisman, Ph.D.
- Extensive experience in cell therapy CMC operations including development and cGMP manufacturing from Phase 1 to commercial-ready processes
- Strong CMC regulatory background for early and late phase cell therapy and protein molecules
- Broad experience in protein fermentation, purification, and formulation with expertise in biophysical characterization
DIRECTOR OF FINANCE AND OPERATIONS
- Former CFO and Vice President-Business Development at Boulder Ionics, a specialty chemical manufacturer providing electrolytes for advanced energy storage where he negotiated multi-year joint development and license agreement with CSIRO, the national laboratory of Australia and negotiated a $4.3 million Venture Capital – Series A Preferred Stock investment.
- Former COO and CFO at Compositek, a contract manufacturer of carbon-fiber parts for aerospace, medical, and transportation companies requiring highly engineered parts made in an ISO 9000 quality environment.
- 30 years financial and business development leadership in manufacturing, distribution and software development companies.
- Former President of the Board of Trustees and Treasurer at St. Anne’s Episcopal School
- Former board member at the Kempe Children’s Foundation
- Bachelor’s degree from the University of Colorado
- M.B.A. from the Kellogg School of Management at Northwestern University
Roger Giller, M.D.
- Over 30 years of experience in laboratory research, clinical research and patient care in the fields of human bone marrow transplantation and other forms of cellular therapy
- Founded, then led and maintained regulatory compliance of the Pediatric Bone Marrow Transplant Program at Children’s Hospital Colorado / University of Colorado School of Medicine for 23 years (1993 – 2016)
- Extensive patient care and clinical research expertise in hematopoietic stem cell transplantation, pediatric cancer, nonmalignant blood diseases and immunologic disorders
Matthew Seefeldt, Ph.D.
DIRECTOR OF CELL THERAPY
- Eighteen years of experience in biotechnology manufacturing, with an emphasis on translating early-stage therapeutics into the clinic.
- Developed six IND-enabling cGMP processes on both microbial derived proteins and cell therapy products. One of those products was successfully scaled to support Phase III clinical studies.
- Successfully completed the build out and GMP preparation of the Gates Biomanufacturing Facility .
- Considered a world expert in protein refolding
- Expert in protein stability and formulation, with specific understanding of the link between aggregates and immunogenicity
Christopher Garbe, M.S. M.B.A.
DIRECTOR, QUALITY – GATES BIOMANUFACTURING FACILITY
- 20+ years’ experience in the design, qualification and operation of process/analytical development and quality control labs in a cGMP setting
- Leader in internal and external Quality operations for start-up and large pharmaceutical organizations to support recombinant protein, nucleic acid and cellular therapy (CAR-T, TCR, cord blood) products as they progress from pre-IND to clinical trials through commercial approval
- Responsible for the translation and technology transfer of multiple drug substance and drug product manufacture and quality operations within academic, industrial and contract manufacturing settings
- Author of numerous Chemistry, Manufacturing and Control regulatory submissions to support IND/BLA/MAA applications and post-marketing approvals
- B.S. in Chemistry from Rensselear Polytechnic Institute, M.S. in Biochemistry and Molecular Biology from George Washington University, M.B.A. from McCombs School of Business – University of Texas – Austin
Branden Antonio Salinas, Ph.D.
DIRECTOR OF PROTEIN DEVELOPMENT AND MANUFACTURING
- 10 years of corporate Process and Product Development experience with therapeutic and industrial proteins
- Early and Late Phase Drug Development experience
- Owner’s Engineering Project Manager for a large Greenfield API Facility
- Expert in protein solubility and stability
- Experienced troubleshooter and technical problem solver, bridging science and engineering to solve yield, quality and process robustness issues