If you work in the cell and gene therapy supply chain, you may have come across the term Chain of Identity (COI) in relation to personalized medicine. But what exactly is the Chain of Identity and how is it applied in cell and gene therapy? In this article, we will provide a comprehensive explanation of COI, highlighting its significance, the challenges it poses, and the measures that can be taken to ensure accurate, consistent, and safe COI tracking.
- What is COI?
- Why is Chain of Identity important?
- How to implement accurate COI tracking
What is COI?
Chain of Identity (COI) can be defined as the permanent and transparent association of a cell or gene therapy’s unique identifiers from procurement of tissue or cells throughout the full product lifecycle including post treatment monitoring
In simple terms, COI involves the use unique references to clearly connect an individual patients and their matching samples or drugs from the beginning to the end of their treatment. It ensures patients receive the correct treatment and is essential for establishing the safety, quality and efficacy of cell and gene therapies.
Chain of Identity is intrinsically tied to patient identity. But, sensitive personal information used to identify patients, such as their name or date of birth, must be protected within the supply chain. So, we don’t pass on this personal data unguarded. For patient safety purposes, we need to be confident that the identity is completely clear, hence the use of an anonymized COI identifier.
COI identifiers can take different formats but are essentially unique alpha-numeric references that identify the cell or gene therapy (single or multi dose/product) that provides a bidirectional link between the donor and the intended recipient. As a therapy physically moves through the supply chain, the systematic exchange of the COI identifier along with labelling and verification steps then ties it to the patient and a Chain of Custody (COC) is formed as the therapy changes hands.
COI vs COC? What is the difference?
Another abbreviation that you will often hear in relation to Chain of Identity is Chain of Custody (COC). This is because it compliments COI as cells physically move and exchange hands through the cell and gene therapy supply chain.
COC is defined as the concurrent, permanent, auditable documentation illustrating the guardianship of a cell or gene therapy product from its origin through its final disposition. It is particularly important for shipments that are time or condition sensitive, as it can help guide investigations when necessary and aid tracking.
Whilst the COI starts at patient enrollment, the COC starts at the point where there is something to have ‘custody’ of, for example, once cell collection takes place. The COC then tracks all patient-specific materials throughout the journey and creates a log of who is responsible for them at each stage.
Why is Chain of Identity important?
Within autologous therapies (medicines that use a person’s own starting material) or matched allogeneic therapies (where starting materials come from a genetically suitable donor), the COI is essential for ensuring patient safety. These drug products are made for a specific patient. Delivering the therapy to any other patient, even one who is also prescribed the same therapy, could cause harm or result in death. Prescribing the incorrect therapy can also prevent the therapy from being a treatment option for that patient in the future. This means it is critical that the identity of patients is reaffirmed at each step of the process to ensure they get the correct treatment.
As this is a patient safety concern, the approving authorities take the issue of COI for personalized medicines extremely seriously. Therefore, a therapy developer who cannot demonstrate that COI can be safeguarded for every patient, is unlikely to be able to progress their therapy through clinical trial.
The US-FDA has established labelling regulations as a part of CFR 21 Part 1271.90 that drive compliance and the EU has established several similar directives including 2002/98/EC, 2006/86/EC and 215/565. Therefore, proper labelling for personalized therapies is critical to success, both in terms of treating patients safely and in getting a drug product approved for trial and commercial use.
Why is Chain of Identity so complex?
Accurately establishing the COI is a complicated process that poses a number of challenges. Below are some of the areas where therapy developers may struggle and the solutions that can mitigate these issues.
Generating a Unique Chain of Identity Number
The COI number is generated on patient registration following prescription or patient enrollment into a clinical trial. This may take place at geographically disparate sites that might not even be part of the same parent organisation.
Every COI needs to be unique to that patient and recognisable throughout the supply chain. Having an automated system generate these numbers consistently, or simply record them and check for duplication, can prevent potential errors.
Chain of Identity Accessibility
The COI will need to be checked at every process point in the supply chain – this will need to happen at many sites and be done by a range of different stakeholders. However, as you can imagine, manually tracking, notifying and monitoring the COI is a time consuming process with high potential for the introduction of human errors.
Thankfully, a cellular orchestration platform can facilitate these checks in real-time without the data leaving the therapy developer’s control or exposing other information unnecessarily.
Multiple Supply Chain Routes
As therapies scale, supply chains become more complex, with multiple sites or partners handling various parts of the process. This extends both the number of tracking points and the variability of the therapy path.
Without an automated system tracking and documenting the process, consolidation needs to happen manually (such as via email or using a COI tracking spreadsheet). As more parties are involved there is a much higher risk of errors, longer administrative procedures, and it becomes increasingly difficult to successfully track and validate products.
Reporting and Auditing the Chain of Identity
The record and document consolidation needed to create a full audit trail manually is time consuming, and the ability to search and report events tends to be limited.
With a digital orchestration system, all of the events and documents that make up the COC and COI are ‘tied’ together in a fully reportable and searchable format. This means they can be easily accessed, output and scrutinised for reporting or auditing.
How to implement accurate COI tracking
As we have explored, manually tracking the COI can lead to potential issues, delays and inaccuracies. Automating this process through the use of COI tracking software , such as a Cell Orchestration Solution, enables secure, efficient and effective tracking.
When selecting a COI tracker, it is essential to consider compliance, accuracy and patient safety. Both OCELLOS and OCELLOS Lite have been built with COI and COC in mind – ensuring that data security, patient safety and quality processes are supported throughout the therapy journey. These solutions provide real-time tracking and notifications to the relevant stakeholders, ensuring potential issues can be reviewed, mitigated and actioned in a timely manner. Furthermore, both OCELLOS and OCELLOS Lite have a full audit trail which can be searched, reviewed, and downloaded by authorised users, during or after the therapy journey.
Chain of Identity tracking is just one element of a successful patient journey, read Pharma Manufacturing’s blog on other strategies for personalized medicines to learn more. If you’re looking for a way to improve your COI tracking, compliance and accuracy, why not arrange a free demonstration with one of our team to see how we could help you with one of our specialist solutions. Simply fill out a contact form and we will be in touch.
If you’re still unsure about how orchestration could transform your supply chain, download our free datasheet on Why and When Orchestrate.
Article by Helen Hopkins - 28 Mar 2023