|
Our Mission
The Center for Biomedicine & Genetics is dedicated to facilitating the development of innovative biologics created by City of Hope investigators, colleagues and partners for the therapeutic benefit of patients with cancer, diabetes, viral disease and other life-threatening illnesses, and to establishing working relationships with regional biopharmaceutical and academic organizations.
Partnership Opportunities
City of Hope anticipates making accessible available space to interested academic and biopharmaceutical parties, through a variety of possible arrangements. Contact our office for more information.
Capabilities
The Center for Biomedicine & Genetics (CBG) functions as a centralized facility and shared resource, available for multiple investigators both on and off campus. The facility will increase and strengthen relationships with biotechnical and pharmaceutical companies, making City of Hope a valuable resource for these companies by utilizing the Center’s capabilities for producing new biological reagents for treatment of human diseases.
In addition, this state-of-the-art, purpose-built facility will support phase I and II clinical trials at the City of Hope National Medical Center through pilot-scale cGMP production of:
- Biologicals
- Viral and non-viral gene therapeutics
- Modified patient cell populations
The design of the facility allows for these three processes to be performed simultaneously, under Current Good Manufacturing Practices (cGMP), in functionally isolated areas of the building.
About Our Facility
The CBG is a two-story, 20,000 square-foot, technologically advanced facility designed to accommodate the cGMP manufacture of promising new biological therapeutics. Features include:
- Specialized "zones" for viral biologicals, non-viral biologicals and cell manipulation
- 13 production and purification suites, served by dedicated fill-and-finish, equipment, glassware and quarantine areas
- Separate air-handling, entries, gowning areas and exits, ensuring complete isolation of simultaneous production processes
- Quality Control, Quality Assurance and product release storage and management
- Regulatory affairs and product and process development assistance.
Capabilities
- Class 100/1000 aseptic fill
- 2000 gallons/day RO/DI
- WFI clean stream
- cGMP autoclave, glasswasher, depyrogenation
- BL-3 containment capability
- Fully key-card-restricted access
- Cryogenic storage
- House CO2, medical grade air, N2 or other gases
- Validated monitoring of all equipment, HVAC equipment and pressurization
Technological Expertise
While the CBG is designed to accommodate a wide variety of biological production and purification processes, specific expertise and procedures exist, or are being developed, in the following areas:
- AAV, adenovirus, retrovirus production
- Plasmid DNA production
- Monoclonal antibody production
- Hematopoietic cell purification, transduction, propagation
About Our Staff
City of Hope has staffed the CBG with a team of individuals with extensive biopharmaceutical expertise in the areas of cGMP manufacturing, viral and non-viral vector design, production and purification, monoclonal antibody production, regulatory affairs, quality assurance and process and product development.
Sponsors
City of Hope is deeply grateful to the sponsors who made the Center for Biomedicine & Genetics possible, including the National Office Products Industry.
For more information about the Center for Biomedicine & Genetics, please contact:
Larry A. Couture, PhD
Sr. Vice President, Center for Applied Technology Development
City of Hope Cancer Center
1500 E. Duarte Road
Duarte, California 91010
626-256-8728
lcouture@coh.org
|