Chain of identity and chain of custody establish and maintain an undisputed connection between the patient and the treatment throughout the end-to-end logistics and manufacturing process.
- COI is the ability to associate a product to its unique patient and processing identifiers throughout the entire treatment cycle.
- COC refers to the continuous tracking and documentation of changes in possession as the product moves from one party to another.
To manage and minimize risk to COI and COC in autologous cell therapy facilities, we have seen best practices focus on physical facilities, management policies and documentation.
The design and setup of physical facilities can have a big impact on reducing COI and COC risk. One example is having a material receipt dock with adequate space and configuration to allow immediate inspection at arrival. Material receipt teams examine temperature, quality, and key identifiers before issuing the material to the manufacturing suite.
As a facility may have multiple manufacturing suites running processes in parallel, it is crucial for each to have independent utilities and ventilation systems to avoid cross-contamination. In situations where a facility has been adapted to use for cell processing, it is essential to ensure that ventilation and utilities are appropriate for this new use.
Since these are patient-specific treatments, it is very important to clearly differentiate materials in cryostorage. This can be done through physical segregation of patient samples and for “in process” versus “final” materials, and by using visual signals, such as clearly labeled storage racks.