Standardizing Compliance for Cell and Gene Transport with ISO 21973 

It’s no secret that the cell and gene therapy market is one of the top-grossing markets within the life sciences industry. According to Nova One Advisor(1), the global cell and gene therapy market size was estimated at $18.13 billion in 2023 with North America accounting for over 50.85% of revenue share. With the average cost of a cell and gene therapy treatment reaching $1 million per dose(2), the need for standardization when transporting these therapies has never been more pressing to achieve universal protection of these valuable commodities. 

In 2020, a new standard of compliance was defined by the ISO/TC 276 Biotechnology Technical Committee with the help of experts from Cryoport Systems for the transportation of cells for therapeutic use. Our new white paper, ISO 21973: How to Ensure Full Compliance Throughout Every Step of the Journey, defines this new standard that aims to deliver these inherently fragile therapies to patients at speed and scale with absolute consistency. Here’s a breakdown of the six key areas of this standard that we cover extensively in our white paper. 

1. Cell Transportation Specification

   This specification gives product-related information provided by the client or manufacturer that determines the requirements for transportation. This information must be shared with the transportation service provider (TSP) who will then conduct the transportation in accordance with the specifications.  

   Requirements:  

   Specification information should include:  

   • The appropriate regulatory classification (e.g., infectious, genetically modified).  
   • Storage and handling conditions (e.g., temperature range, shelf life).  
   • Shipping information (e.g., description of goods, commercial value, weight, consignor/consignee information). 

2. Shipping Container and Labeling

   Best practices should be used to guarantee safe transportation and optimal product quality and integrity.  

   Some requirements of this section include:  

   • The shipping container should be designed to protect the payload and anyone who comes into contact with the container.  
   • The functionality of the shipping container should be adequately validated and documented to ensure the product is maintained at an optimum temperature throughout the transportation process.  
   • For reusable shipping containers, records should be maintained relating to performance, commodity, cleaning, and maintenance. 

3. Operation

   The client or TSP should make sure the shipping container is prepared and labeled correctly and that data loggers or condition monitoring systems are set appropriately.  

   Some requirements of this section include:    

   • Transportation should be performed according to the transportation specification to maintain chain of custody, chain of condition, and chain of identity. Once sealed, the shipping container should not be reopened. The records of all processes in transportation should be retained, including the time of collection and delivery plus the signatures of consignor, consignee, and transportation personnel.  
   • Visual inspection reports at each hand-off point should be documented. These checks should include any physical damage to the shipping container, any obvious liquid leakage, and any damage to the tamper-evident seals. Once delivered, further checks to the primary container and analysis of data from the data logger should be carried out. 

4. Organization

   The TSP must have a suitable Quality Management System in place.  

   The Quality Management System should minimally include:  

   • A documented Quality Policy 
   • Organization structure 
   • Appropriate processes and procedures 

5. Storage

   If it is necessary for the shipment to be temporarily stored during transportation, the facility should meet the appropriate requirements for the storage of cells for therapeutic use.  

   Some requirements of this section include: 

   • The facility should be secure with suitable access control. Procedures should be in place for pest control and the cleaning of equipment and premises to prevent any form of contamination.  
   • A procedure must be in place to address any malfunction or failure of equipment or shipping containers while at the facility. 

6. Documentation

   All documentation generated during the transportation process must be properly maintained for every scheduled or unexpected event.  

   Some requirements of this section include: 

   • The history of any reusable shipping container should be documented and retained
   • All documentation should be regularly reviewed and updated using a version-controlled document control system

To review the comprehensive standards and best practices for transporting cells for therapeutic use, access ISO 21973: How to Ensure Full Compliance Throughout Every Step of the Journey. For more information on how Cryoport Systems utilizes this standard throughout our platform of supply chain solutions, request more information on our website. 

1. Cell and Gene Therapy Market Size Report, 2024-2033. (n.d.). https://www.novaoneadvisor.com/report/cell-and-gene-therapy-market  
2. Staff, G. (2023, December 27). Cell and gene therapy manufacturing costs limiting access. GEN – Genetic Engineering and Biotechnology News. https://www.genengnews.com/insights/cell-and-gene-therapy-manufacturing-costs-limiting-access/