Center for Biomedicine and Genetics

The Center for Biomedicine & Genetics (CBG) is a California-licensed, 20, 000 square foot, multi-product biologics manufacturing facility. With twelve ISO 7 production rooms in three product type “zones,” a dedicated aseptic fill suite, and a staff with extensive biopharmaceutical experience, the CBG is capable of producing virtually any type of biologic at scales suitable for Phase I through Phase II clinical trials.

Capabilities

Aseptic fills
Cell therapeutics
Viral vectors
Therapeutic vaccines
Recombinant proteins
iPSC & hESC products

CBG’s two-story, 20,000 square-foot, state-of-the-art secured building features:

10,000 square feet of biologics manufacturing space (clean rooms) in three specialized zones: — Viral vector zone — processes in development include adenovirus, retrovirus, adeno-associated virus, lentivirus
DNA and protein production zone – 13 production and purification suites served by dedicated aseptic fill-and-finish with an air-handling system for class 100/1000 sterile materials, equipment, glassware autoclave/glasswasher and quarantine areas
Cell engineering zone – processes in development include ex vivo T-cell and islet cell manipulation

These zones have separate entries, gowning, air-handling and exits to ensure complete isolation of simultaneous production processes.

Water facilities: clinical-grade water generator system (2,000 gallon/day capacity); water for injection steam generator for sterilization
Cryogenics storage rooms
Irradiator facilities
Four-gas storage system
Quality Control, Quality Assurance and product release storage and management

In addition, this facility supports phase I and II clinical trials at City of Hope through pilot-scale cGMP (current Good Manufacturing Practices) production of:

Biologics
Viral and nonviral gene therapeutics
Modified patient cell populations

The design of the facility allows for these three processes to be performed simultaneously, under cGMP, in functionally isolated areas of the building. Further important features include:

WFI clean stream
BL-3 containment capability
Key-card-restricted access
Provisions for CO2, medical-grade air, N2 or other gases
Validated monitoring of all equipment, including HVAC and pressurization equipment

Technological Expertise

While CBG is designed to accommodate a wide variety of biological production and purification processes, specific expertise exists in the following areas:

Lentivirus, retrovirus, modified vaccinia Ankara, recombinant pox virus and herpesvirus
CAR-T and CAR-NK cell products
Monoclonal antibody production
Hematopoietic cell purification, transduction and propagation

CIRM Translating Center

The Center of Biomedicine and Genetics (CBG) has been awarded funding to provide core services to support the California Institute for Regenerative Medicine (CIRM) Translating Center with activities related to process development and manufacturing and preclinical research necessary to obtain Investigational New Drug (IND) application, which is a prerequisite for clinical testing of cell therapy product candidates.

Forms

Staff

Manufacturing

Taby Ahsan, Ph.D.
VP, Cell Therapy Operations
[email protected]
626-256-4673

David Hsu, Ph.D.
Senior Director, Process Development
[email protected]
626-256-4673

Stephen Lin, Ph.D.
Director, Cellular Immunotherapy GMP Manufacturing
[email protected]
626-218-5270

Kerry Dooriss, Ph.D.
Director, GMP Manufacturing
[email protected]
626-218-7159

Quality Systems

Rajiv Srinivas Nallu
Quality System Director
[email protected]
626-256-4673

Regulatory Affairs

Catherine Cortez
Regulatory Affairs Director
[email protected]
626-256-4673

Administration

Michael Shaw, M.P.H.
Senior Business Manager
[email protected]
626-256-4673

Ivy Derecho, M.S.
Senior Project Manager
[email protected]
626-256-4673