The UC Davis GMP facility will be a multi-use, clean room facility, with high flexibility and versatility, for the production of clinical grade therapeutics. Among its standout features are:
- Six manufacturing rooms (certified Class 10,000 ) for clinical grade manufacturing of cellular therapy products, recombinant DNA, gene therapy products, vectors and also small molecules for therapeutic applications;
- Three intermediate labs (certified Class 100,000) for unidirectional access and egress, also for product storage with temporal and spatial segregation;
- Custom designed, switchable and validated air pressure gradient system to isolate manufacturing, intermediate and gowning/de-gowning rooms from each other, allowing for GMP grade FACS sorting and vector production areas;.
- Cell and tissue imaging room;
- GLP scale up/quality control testing laboratory;
- Automated facility monitoring, controlled by manual monitoring through personnel seven days a week;
- Environmental monitoring, including touch and settling plates and active air sampling with alert and action levels;
- Environmental cleaning on a daily basis;
- Annual recertification.