Maintaining excellence in a high volume academic cell therapy production facility through optimization of space utilization, operations, scheduling and staffing

Background & Aim The Clinical Cell and Vaccine Production Facility (CVPF) at UPenn is a FACT accredited resource with a 25 year record of novel first-in-human cell and gene therapy clinical trials. CVPF is integrated with research, process development, and correlative studies laboratories, QC/QA, clinical operations and monitoring, apheresis facilities and infusion sites. CVPF has two clean room facilities in which cell immunotherapy products are currently manufactured in support of >15 investigational new drug (IND) protocols. Methods, Results & Conclusion CVPF recently developed a clean room space utilization model to increase production capacity. Previously, a product occupied a single processing suite for the length of manufacture. Improvements to the processing room layout and implementation of a “bioreactor nursery” allowed for expansion of multiple products in a single space. Other benefits included fewer equipment pieces required and built-in redundancy. Additionally, we developed a standardized production slot model to reduce the rate of unfilled manufacturing slots and maximize facility efficiency. A standardized schedule along with the application of scheduling software has improved resource management, effort tracking, production task scheduling and capacity projections. Standardized scheduling is more efficient in scheduling manufacturing staff, sample transport, environmental monitoring, facility cleaning, equipment maintenance, QC testing, batch record preparation and review and product release. We developed an accelerated training program that reduced time-to-proficiency (TTP) for new hires through resource assignment, dedicated training space and re-designed curricula. A mock processing suite was established outside of the clean room space to allow for non-GMP materials to be used during training, greatly reducing cost. Still, staff recruitment, retention and training continue to be a challenge for academic manufacturing facilities as staff renewal limits production capacity and results in fewer patients enrolled in clinical trials. CVPF joined forces with University leadership to develop a novel metrics based career advancement track for cell therapy technologists. These techniques for increased productivity coupled with improved training methods and staff retention initiatives can be adopted by academic cell therapy facilities to optimize staffing, reduce costs and increase efficiencies, thereby increasing production capacity and patient clinical trial enrollment.