April 23, 2019
Cell therapy labels that work — pointers to keep your patient and your product in sync
In cell therapy, smarter labeling means greater safety and speed.
If you’re a cell therapy developer, you have a make-or-break moment every time a patient’s cells are collected at a healthcare center. These fragile, living raw materials can be easily packaged and shipped to you for manufacturing — or they can get stuck in the medical center, caught up in confusion or paperwork, losing precious time and viability.
The speed you need depends, in part, on your in-process labeling — the identifications affixed to each patient product as it moves through the manufacturing and delivery process. These in-process labels make sure that each personalized drug product stays linked to its intended patient, every step of the way.
If your labeling works smoothly, so does your overall process. If your labeling process breaks down, safety issues flare up and gridlock can ensue. In-process labeling may sound straightforward — but in cell and gene therapy, it’s often not.
The topic is of such importance that I was invited to give a standards-setting webinar on labeling. Given how often labeling comes up — it’s one of the challenges Vineti is asked about most — we wanted to share a few of the highlights here.
Point #1: your labels enable your Chain of Identity
When a patient is providing essential biological material for a personalized therapy, you need to make sure that drug product stays linked to that patient every step of the way. With a personalized product, any failure of that linkage can compromise patient safety. Your in-process labels on your drug product, starting with cell collection and moving through the manufacturing and infusion process, are a key factor in that patient-to-product connection.
For reference, here are working definitions for Chain of Identity and Chain of Custody in the context of cell therapy.
Point #2: the existing standards need updating to support cell and gene therapies
Multiple regulatory agencies and standards-setting bodies have provided labeling guidance for traditional off-the-shelf therapeutics and tissue donation.
Here’s an example of an in-process ISBT label format, used across 77 countries and six continents.
And here’s an example from a label formatted according to the requirements of the Single European Code.
Here’s a look at FDA requirements.
What’s the challenge with the current practices and standards? While they provide a foundation, the current guidances may not always be flexible enough to accommodate the evolving needs of personalized therapies or cover the entire supply chain. In the EU, for example, how should potentially conflicting guidances on patient safety in cell therapy versus patient privacy regulations be reconciled? Too often right now, these questions may get addressed on a case-by-case basis. Updated standards would help our entire industry. In a great step forward, the Standards Coordinating Body has indicated an intention to address Chain of Identity standards, including labeling, as a priority.
Point #3: data drives each product — and labels
Safety and speed in cell therapy rely as much on data capture and management as handling of the physical product. And since that data collection starts in a medical facility, you need to make the whole process as simple and reliable as possible for the doctors and nurses who help collect a patient’s cells and then deliver the final treatment.
For a personalized drug product, patient specificity is captured at every step, and some of it is required for your labels. Here’s a look at the cumulative data capture and label creation in cell therapy.
Digital technologies to manage personalized cell therapy supply chains can help with this data capture — and related label generation.
How are you handling cell therapy labeling? What are your biggest challenges? Please send us a message.
Heidi Hagen is the Chief Strategy Officer and Co-founder of Vineti. If you’d like to see all the labeling slides from Heidi Hagen’s Standards Coordinating Body webinar, please download them here. If you’d like to learn more about how Vineti’s Personalized Therapy Management (PTM) platform and labeling solution can help you solve your labeling challenges, please contact us.