Cell therapy standards in action -- a new case study on labeling
by Heidi Hagen | June 19, 2019
In cell therapy and gene therapy, in-process and final product labeling matters more to patient safety than ever before -- and it’s also more complex.
You have to ensure that the right drug product makes its way to the right patient. Your labels can either enable that critical supply chain flow, or break it.
So here at Vineti, we’ve been working with other industry leaders on new and updated standards for cell and gene therapy labeling. This week, the Standards Coordinating Body published a case study on our collaboration to use standards to address labeling challenges for cell therapy products.
The challenge: “Labeling standards for these products were originally designed for one-way donation processes and do not account for the complexity of the autologous therapy supply chain. This fragmented process can result in the loss of information critical to product safety, as stakeholders often capture information in different ways at each step.”
The solution: “The team at Vineti—a digital cell and gene therapy traceability platform—is working with the Standards Coordinating Body (SCB) and industry stakeholders to address these challenges with more robust and specific standards. Their efforts include:
• Promoting updates to existing labeling standards, including the ISBT 128 standard for the labeling of blood components and Commission Directive (EU) 2015/565 on the technical requirements for the coding of human tissues and cells
• Advancing new standards to fill emerging needs specific to regenerative medicine, especially in the areas of chain of identity, chain of custody, and data acquisition
• Educating the regenerative medicine community on the need for standards and the benefits of standards to both individual organizations and the whole community”
Lessons learned: “Based on their experience, Vineti encourages stakeholders interested in supporting standards advancement to work collaboratively and think about needs across the entire therapy supply chain, not just at their organization’s specific step in the process. By considering how each step ties back to the overall patient experience, we can arrive at solutions that will allow these new therapies to gain the broad support and public confidence they need to flourish.”
We’re grateful to the SCB for the opportunity to collaborate on this case study, and we’re looking forward to more! The labeling process is just one example of a value chain challenge that needs new solutions. The SCB has been pulling together stakeholders and information to tackle dozens of these challenges. We encourage everyone interested in cell and gene therapies to review the SCB’s latest draft report on needed standards and get involved!
At Vineti, our software platform helps our partners manage complex cell and gene therapy workflows every day. Please contact us if you’d like to learn more, either about our platform or working with the SCB.
Heidi Hagen is the Chief Strategy Officer and a Co-founder of Vineti. Over the course of her career, she has overseen the operations and delivery for more than 100,000 doses of cell therapy. If you’d like to learn more about how Vineti’s software platform supports advanced therapy workflows, please contact us to schedule a demo.