Summary
This guide focuses on the complexities involved in scaling CAR-T operations for life sciences leaders. It outlines critical areas such as manufacturing and contamination control strategies, product definition, user requirements, and quality and regulatory approval strategies. The document details the importance of a comprehensive validation strategy, including risk assessments and lifecycle documentation requirements. Additionally, it emphasizes the need for a quality management system and effective project management to ensure operational readiness. The guide also discusses the significance of engaging facility and technology experts early in the scaling process to streamline operations and avoid potential pitfalls. It highlights the urgency of meeting market demands for CAR-T therapies and the necessity of a well-planned supply chain strategy to prevent delays. Overall, the guide serves as a resource for leaders aiming to navigate the challenges of CAR-T therapy production and achieve successful commercialization.
