Current Good Manufacturing Practice Facility

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT - CURRENT GOOD MANUFACTURING PRACTICE FACILITY (CGMP) The Current Good Manufacturing Practice Facility (cGMP) supports access to state-of-the-art cell production, equipment and regulatory knowledge to facilitate the development and execution of cell therapy clinical trials for University of Chicago Medicine Comprehensive Cancer Center (UCCCC) investigators. In the last review, the cGMP Facility was a Subcore of the Human Immunologic Monitoring-cGMP (HIM-cGMP) Facility. The cGMP Subcore was initiated as a Developing Core in 2001, supported by UCCCC Developmental Funds and additional philanthropic funds. In 2011, the HIM Facility formally merged with the cGMP Facility, but as a result of center-wide strategic planning, the HIM-cGMP has now been divided into two separate cores in this renewal application. A new addition to the cGMP facility is a Vector production suite (March 2023) for clinical-grade retro/lentiviral vectors and oncolytic viruses, which is led by Richard Koya, MD, PhD. The primary objective of the cGMP Facility is to provide investigators with services and expertise for the manufacture of cGMP compliant cellular therapy products e.g., Dendritic cells, engineered T cells and preparation of agents for administration to patients. The cGMP Facility has the requisite scientific, technical and regulatory expertise and operational efficiencies in cell-based immunotherapies, to implement Phase I and II clinical trials. In the reporting period, cGMP supported 24 clinical trials and 19 unique UCCCC members (5% MMC, 5% CPC, 5% IC, 84% CET), meeting the strategic objectives of UCCCC. The cGMP facility has administered (injections and infusions) over 385 doses of cellular products into patients, with zero contaminated products over the past 5 years. Our future goal is to increase the number of UCCCC investigators utilizing the cGMP by optimizing several new processes and procedures and ultimately reducing cost. In this regard, cGMP plans to: (i) optimize automation, purification, and expansion methodologies. Recently, the cGMP has invested in automated fractionation and cell wash equipment, i.e., CliniMacs Prodigy and the LOVO. With this investment, the Therapeutic Cell Processing (TCP) facility will be able to (i) make the manufacturing process more uniform, and to increase the TCP production capabilities; (ii) increase the scope of cellular therapy products that can be manufactured by investing in GE Wave, SEPAX C Pro, and Sefia (which will allow for the automated, closed and dynamic manufacturing of diversified cell therapy products); and (iii) as the need for TCP manufacturing expertise increases, TCP will furnish the FLEX room (fourth manufacturing cleanroom), with standard cell processing equipment.