Implementation of Compliant cGMP Cell Production Infrastructure: From Zero to a One-Stop-Shop
Complimentary
Learning Level: Basic
Time: 1100 - 1200 ET
Session Length: 1 hour
Cell replacement therapies offer functional recovery for devastating neurodegenerative conditions with enormous medical and economic consequences, but clinical cell manufacturing frequently entails a substantial financial burden. This limits the capabilities of academic or hospital centers to develop safe, compliant, and competitive facilities fit for early phase clinical trials and the manufacturing of investigational new drugs. Moreover, compliant cGMP operations often call for a distributed network of third-party contractors for the implementation of various aspects of clinical manufacturing: from conducting quality control assays to training and developing personnel expertise, to establishing safe and reliable document control systems, to name a few. The present report will outline the development of an in-hospital cGMP cell manufacturing facility with adjacent quality control and in direct proximity to patients, and demonstrate the challenges of developing a compliant and all-inclusive program at cost. We examine all aspects of operational development:
- Cost-effective and compliant processes, logistical challenges, and rapid knowledge evolution;
- Personnel education and development with an emphasis on transparency, dependability, and a healthy work environment;
- Risks and potential pitfalls of creating a safe and sustainable manufacturing environment from the ground up: navigating unforeseen challenges to construct a robust quality and risk management system.
Objectives
- Objective 1 is to expose the logistical, personnel development, and knowledge management challenges inherent in the development of a cGMP facility for clinical cell manufacturing within an academic/hospital setting, and to discuss effective, feasible, and creative solutions resulting in successful and safe operations.
- Objective 2 is to discuss the personnel and process management obstacles, challenges, and constructive solutions that enable a small start-up to evolve into a cost-effective, safe, compliant, and collaborative one-stop-shop facility for early phase clinical trials.
- Lastly, we discuss the inherent risks and potential pitfalls accompanying the development of a compliant infrastructure required for the manufacturing of safe autologous cell products. We go over the creation of document control, process development and validation, personnel education, and quality control infrastructure and elaborate on lessons learned in the early years of facility development.
