Center for Advanced Biotherapies
Broad Stem Cell Research Center (BSCRC)
Overview
The UCLA Center for Advanced Biotherapies (CAB) is dedicated to accelerating the translation of innovative laboratory discoveries into life-saving clinical therapies. CAB supports UCLA investigators as well as academic and industry collaborators by providing the expertise, infrastructure, and regulatory framework necessary to advance cutting-edge biotherapeutic products.
Located within the UCLA Center for Health Sciences, CAB is a state-of-the-art Good Manufacturing Practice (GMP) facility that significantly expands upon the capabilities of UCLA’s highly regarded Human Gene and Cell Therapy Facility (HGCTF). CAB continues UCLA’s leadership in regenerative medicine and stem cell research while broadening the scope to support a diverse range of advanced biotherapies.
Leadership
Contact
To get started, interested collaborators can email to get the CAB Application/Intake Form.
Areas of Expertise
CAB is equipped to support the development and manufacturing of a wide range of advanced therapeutic platforms, including:
- Personalized CAR-T cell therapies
- Custom-engineered dendritic cell vaccines
- Hematopoietic stem and progenitor cell-based gene therapies
- Induced pluripotent stem cell (iPSC)-derived therapies
- Autologous and allogeneic natural killer (NK) cell therapies
- Other novel bioengineered and cell-based products
Facility Overview
CAB encompasses approximately 14,000 square feet of purpose-built GMP space, including:
- Eight cleanrooms dedicated to cell and gene therapy manufacturing
- Two large-scale bioengineering suites for complex processes and specialized equipment
- Designated areas for material management and storage
- Controlled environments for cryopreservation and long-term storage
- A fully equipped analytical Quality Control (QC) laboratory
- Administrative and office spaces
Quality and Operational Excellence
CAB operates under a robust quality management system designed to ensure the highest standards of compliance, safety, and product integrity. Key operational features include:
- Controlled facility access and stringent cleaning protocols
- Continuous monitoring of environmental conditions, air pressure, and critical equipment
- Routine preventive maintenance and equipment calibration
The CAB quality system encompasses:
- Management of out-of-specification (OOS) results and investigations
- Oversight of non-conforming materials and products
- Deviation management for equipment and processes
- Change control procedures
- Corrective and preventive actions (CAPA)
- Product review and release processes
- Vendor qualification and auditing programs
Services
CAB provides comprehensive, end-to-end support across the product development lifecycle, from early-stage process development through clinical manufacturing:
- GMP Onboarding: Guidance for project initiation and GMP readiness
- CMC/IND Support: Technical expertise for Chemistry, Manufacturing, and Controls (CMC) sections of IND submissions
- Manufacturing: Technology transfer and GMP-compliant production for Phase I/II clinical trials
- Quality Assurance (QA): Oversight of compliance, documentation, and quality systems
- Quality Control (QC): Development, qualification, and execution of compendial and non-compendial assays
- Materials Management: Vendor qualification, raw material control, and GMP-compliant receiving and release
- Cryostorage: Secure liquid nitrogen and −80°C inventory-controlled storage solutions
Pricing and Engagement
Pricing is customized based on the scope and complexity of each project. Investigators planning to utilize CAB services are encouraged to include anticipated costs in grant applications.
For additional information or to initiate a project, please contact: Good Manufacturing Practice (GMP)