Facility Details

Core provides collaborative process development support to investigators across the Center engaged in new Biotherapeutics initiatives. Core staff are responsible for converting research-lab processes into GMP-compliant manufacturing processes. This includes establishing Standard Operating Procedures (SOPs) and batch records for cell processing, cell engineering, and vector production. Provides full support for cGMP manufacturing of cell products: handling patient cells in cGMP environment, from purification and transduction to expansion and formulation, for use in phase 1 and phase 2 clinical trials. Manufactures vector stocks, oversees biosafety and releases testing of generated projects for human use. This includes analysis of patient cells and vector stocks, assessing characteristics such as phenotype, potency, purity, and stability. Gene transfer and expression analyses are also performed. Core performs analytical post-infusion monitoring. For each trial, the Core develops a comprehensive set of analytical tests to ensure quality and safety of the manufactured drug products.