Cell manufacturing innovation facility: use of GMP-compliant space to accelerate advances in therapeutic cell production

Abstract

Background & Aim Production space for cell therapy products is in high demand, with the recent FDA approvals of the first cell therapy products in the U.S. Hospitals are expanding their qualified production spaces to support the growing number of cell and gene therapy clinical trials. Simultaneously, a pronounced need to improve engineering and controlled manufacturing principles has been made clear. Initiatives have emerged to accelerate cell therapy manufacturing innovations at academic institutions, including the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) and the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M). In order for researchers, particularly in engineering and manufacturing disciplines, to have an understanding of restrictions placed on therapeutic cell production, exposure to compliant environments without disrupting production is necessary. The MC3M facility at Georgia Tech provides the community access to facilities operating under GMP-compliant conditions and the ability to develop next generation technologies. Methods, Results & Conclusion The MC3M facility contains two isolated ISO 7/GMP suites for viral and viral-free work, and a large ISO 8 research lab. GMP rooms are adjacent to analytical suites, with pass-thrus to enable real-time analytics and feedback control. MC3M houses various bioreactors, including hollow fiber, vertical wheel, and stirred batch systems, as well as analytics equipment to enable at-line and in-line monitoring within minutes from sampling directly from culture vessels. Additionally, automation technologies that measure and control process parameters such as glucose and lactate are being developed and employed. Faculty, students, and industry can pilot new process technologies for cell manufacturing needs. Users learn proper gowning procedures and operational requirements like material quarantine and environmental monitoring. These experiences serve to better inform researchers in the practical applications of their early technology or culture process improvements, and advance the translation of discoveries to products. The facility is utilized for training purposes beyond the university's community to inform and equip the future workforce of the growing cell manufacturing industry. Facilities like MC3M are imperative to meet the demands of the cell manufacturing industry, and ensure clinically and industry relevant, impactful research is conducted, even at the earliest stages of discovery.