Packaging 25%
The percentage of the ISBT 128 product description codes (3,000) in the database, that are dedicated to cell therapy and tissue products. National Library of Medicine
governments. There are other countries, however, particularly in Africa, where resourcing has proved to be a barrier to adoption. “The problem is that if you don’t have money then it’s difficult for you to print the labels, so they will still do things manually because that is what they can afford,” says Szczepiorkowski. “So their labels, although they may look like ISBT 128 labels, are still filled out in a manual fashion.”
Nonetheless, more than 40 million products are labelled with ISBT 128 every year. These include not only blood and cell products, but tissues (including eye tissue) and human milk. Of the ISBT 128 product description codes in the database, about 25%, or 3,000, are dedicated to cell therapy and tissue products.
“You have to rely on the science of labelling to be sure that the chain of custody is such that at every single point you could be reassured that what you have in your hands is related to the patient at the beginning, so it can go to the patient in the end.”
Crossing borders
The ISBT 128 standard initially set for blood products laid the groundwork for tracking and tracing cell and gene therapies for clinical trials.
Cell and gene products frequently have to be transported across multiple borders. “We have to be able to label those units of bone marrow or stem cells in such a way that we can transport them between the countries fairly easily, so they can be recognised and read in the other country so that we know exactly what’s in the bag,” says Szczepiorkowski. He notes that cell and gene therapies come in two varieties: Autologous, where the cells are taken from the patient, transported to the manufacturing site for processing, and then returned to the patient; or allogeneic, in which the cells are transferred from one patient to another.
Allogeneic products tend to be more straightforward to handle, in that, once donated, they can be stored and selected once needed. On the other hand, In the autologous process, he points out, the manufacturing site could be in the next building or 5,000 miles away, and the process could vary from days to weeks.
“This final product in an autologous setting is for one patient – it cannot go to another patient,” he says. “Multiple checks on the way have to reassure you that the cells which are sent from your hospital for the manufacturing, and coming back as a new product, are actually the cells from that patient.” Given what’s at stake, the life of a patient for whom a specific therapy may be their last chance at beating a disease, it is absolutely imperative that no mistakes are made. “You have to rely on the science of labelling to be sure that the chain of custody is such that at every single point, you could be reassured that what you have in your hands is related to the patient at the beginning, so it can go to the patient in the end.”
Flexible coding system
In a clinical trial, the patient (or subject) enrolled in the trial will be assigned a unique code. The coding system needs to be flexible enough to make sure that the code is linked to the subject throughout the entire manufacturing process. To address this, ICCBBA has, in the last two years, developed a split label design for collection products for further manufacturing, so that the ISBT 128 traceability information would be captured on one side of the label, while the other side would provide space for information specific to clinical trial products. The split label design was incorporated in a new supplementary standard, ST-018.
It is not appropriate to assign an internationally standardised product description code to a product that is still at the trial stage, so ICCBBA also developed a mechanism that enables clinical trial sponsors to be assigned a range of unique product description codes for their own use.
“The idea,” says Szczepiorkowski, “is to look at a chain of identity as a process in which the manufacturer has some freedom of calling different things different names, but also there is a stable part which will assure you that the product we collected from the autologous donor, going back to the patient, will be a constant element going through. It doesn’t matter if it’s Bristol Myers Squibb or Novartis – whoever does the study has the opportunity to use their coding in such a way that they know that it’s their patient, their study, but will also be able to connect the patients with the product.” The success of a standard initially developed for blood products, but which is now being used for a range of other MPHOs is in large part down to its combination of rigour and flexibility. The rigour means that the detail and specificity of the standard vastly reduces the possibility of error, while, as the creation of a split label for clinical trials demonstrates, the flexibility has enabled it to change with the growth in clinical and scientific knowledge. ●
38 Clinical Trials Insight /
www.worldpharmaceuticals.net
ANTONIO TRUZZI/
Shutterstock.com
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