Building A Proactive Strategy For Navigating Regulatory Complexity In CGT Development And Commercialization

Navigating the regulatory complexities of cell and gene therapy (CGT) development can be daunting. With a dynamic environment and few precedents, manufacturers face hurdles in ensuring compliance, especially with novel therapies. Key considerations include developing a robust regulatory strategy, effectively utilizing agency programs like INTERACT or Pre-IND meetings, and standardizing manufacturing processes to meet critical quality and compliance requirements for aspects like potency and comparability.

This article explores strategies to address these challenges and streamline the path to commercialization. Download the article to learn more about building a proactive strategy for navigating the regulatory complexities in CGT development and commercialization.