A Consensus Framework For Raw Materials And Single-Use Systems In Cell And Gene Therapy Manufacturing

Translating cell and gene therapy breakthroughs from research laboratories into commercially viable treatments introduces unique manufacturing and regulatory hurdles. Early-stage design decisions often overlook long-term financial viability and scalability, creating compliance bottlenecks down the road. Mitigating these challenges demands a standardized approach to qualifying both ancillary materials and single-use systems. By integrating a structured Quality by Design framework, manufacturers can effectively define critical material attributes, align specifications with process needs, and strengthen global supply chain resilience. This approach reduces overengineering, establishes rigorous testing benchmarks, and minimizes contamination risks. Review the full infographic for an actionable risk-management framework to accelerate therapeutic development, streamline regional regulatory filings, and secure consistent batch performance.