Example Project: Cell Transportation
Cell transportation is a critical step in the cell therapy workflow to ensure that cells maintain quality, safety, and performance during shipment. In September of 2014, the US Working Group 4 organized a workshop that confirmed and emphasized the need for cell transportation standards. However, challenges lie in the implementation of these standards. The ISO team from Japan has developed a project proposal to address this issue. Resultantly, a group of experts formed by the US WG4 reviewed this proposal in October of 2016 and identified several gaps and needs for specificity. For example, a few needs identified include minimum requirements for IT infrastructure and transportation, shipment tracking and monitoring protocols, chain of custody requirements, and a centralized logistics management system.
In response to this assessment, the US WG4 decided to participate in this project with SCB support. The goal of this project is to develop separate document(s) under the general framework described in the current draft submitted by Japan. The team will develop either one document to address the needs of all involved parties, or two separate documents: one to benefit users (i.e. cell therapy manufacturers) and one to benefit transportation/logistics companies.
This ongoing project is being managed by the SCB in association with the project leads (Claudia Zylberberg [Akron Biosciences] and Jiwen Zhang [GE Healthcare]), and a collaborative group of experts from the cell therapy and transportation / logistics industries. If you are interested in becoming involved with the SCB Cell Transportation Project, please contact us.