Developing the infrastructure to expand manufacturing capabilities of cellular immunotherapy products for treatment of pediatric disease.
Each of the Consortium members operates a cGMP facility which puts them at the forefront of being able to deliver immunotherapy treatments. However, there are gaps in each cGMP including production barriers due to space constraints, lack of sufficient personnel to expand production, competing clinical trials that utilize cGMP resources and lack of experience in multi-site cellular drug manufacturing and distribution.
The cGMP Working Group is tackling these various issues by sharing expertise across sites in a peer-mentoring fashion. The group is developing best practices in multiple areas including shipping/receiving of raw material and final product, supply chain management, and employee training, testing and engagement.
To address the need for additional manufacturing capacity at new or expanding CTSA sites, many of our manufacturing leaders can provide critical consultation services.