Translational Cell Therapy Lab
Our Translational Cell Therapy Lab helps investigators establish clinically-relevant manufacturing processes and conduct the preclinical studies needed to bring cell therapy candidates to clinical trials.
Services offered include providing expert guidance on FDA testing requirements for cell products; assisting in preclinical research studies to assess the product’s safety and efficacy; and establishing processes to manufacture the product under conditions that meet the FDA’s rigorous Good Manufacturing Practices.
By providing access to specialized facilities, staff and knowledge gained from projects that have already advanced through this translational stage, the TCTL accelerates the pace at which projects reach clinical readiness.
Services
- Review manufacturing processes to identify gaps in clinical readiness
- Develop raw materials control strategies
- Create batch records and standard operating procedures
- Test readiness to meet Good Manufacturing Practices FDA regulations that assure the safety, identity, strength, quality and purity of cell, gene and drug products by requiring adequate control of manufacturing for these products. Good Manufacturing Practices FDA regulations that assure the safety, identity, strength, quality and purity of cell, gene and drug products by requiring adequate control of manufacturing for these products. requirements
- Draft Investigational New Drug application A request for FDA authorization to administer an investigational drug or biological product to humans in a clinical trial. Investigational New Drug application A request for FDA authorization to administer an investigational drug or biological product to humans in a clinical trial. materials
- Tech transfer to UCLA Human Gene and Cell Therapy Facility for manufacturing of clinical product
Facilities & Resources
Facilities
- 1,400-square-foot Good Laboratory Practice/Good Tissue Practice-compliant lab space
Resources
- GMP-compatible induced pluripotent stem cell and embryonic stem cell banks
- Inventory control (vendor qualification, warehousing and tracking)
- Regulatory expertise
- Quality assurance support
- Assistance adapting a cell manufacturing protocol to Good Manufacturing Practices
- Assistance with qualification of analytical assays
- Training on manufacturing and regulatory topics specific to cell and gene therapy products
Contact
