The Hidden Risks In Your Supply Chain: How Regulatory Support Can Save Your CGT Program

For advanced therapies, the temperature-controlled supply chain is a regulated, critical extension of your manufacturing process—where quality and compliance are essential at every step. Yet, risks often hide in plain sight that can lead to regulatory delays or product loss. Four of the most common oversights are unvalidated shipping lanes, incomplete packaging documentation, gaps between operational practices and regulatory submissions, and the failure to pre-qualify backup shipping systems.

An unvalidated shipping lane is a gamble, leaving sensitive materials vulnerable to temperature excursions and customs delays that compromise integrity. Similarly, inadequate packaging qualification documentation (missing calibration certificates or stress testing data) can fail to meet regulatory scrutiny during inspections. Addressing these risks requires a proactive, data-driven approach. You must implement robust shipping lane qualifications and maintain audit-ready documentation to provide the necessary evidence for your regulatory filings.

Ensure the resilience of your program by building in redundancy and aligning your supply chain strategy with regulatory expectations from the start. Learn how to address these hidden vulnerabilities with comprehensive qualification and risk mitigation strategies to support a smooth path through clinical trials to commercialization.