May 22, 2019

Cell and gene therapy standards need you!

One week to go! In the next seven days, those of us working in cell and gene therapy have a great chance to give input that will help our industry grow, including in areas of direct focus for Vineti.  

The Standards Coordinating Body, an initiative formed specifically to help advance standards for advanced therapies, has drafted a new Needed Standards in Regenerative Medicine report. Now is the time to weigh in and help finalize it.

The 62-page report covers six key functional areas in regenerative medicine. In some of these areas, our industry has existing standards from traditional off-the-shelf practices to use as a starting point. In others, we need to build from the ground up.  

It came as no surprise to us that existing standards are relatively lacking in an area of daily focus for Vineti — logistics and compliance. In fact, this functional area ranked second-to-last in SCB’s tally of existing standards.

Cell therapy standards

To help fill this gap, the SCB has prioritized five specific areas within logistics and compliance, found on pages 43-47 of the report (we’ve got screenshots of the report content for the first three areas below):

  • Chain of Identity/Chain of Custody Recording
  • Labeling Standards Specific to Regenerative Medicine Products
  • Data Acquisition
  • Cryopreservation Methods
  • Regenerative Medicine Product Packaging
Chain of identity information
Labeling standards information
Data acquisition information

Vineti is finalizing our input to the report, and we encourage all of you to do the same! Standards are crucial to making all of this amazing transformative science work on behalf of all patients. How else will we make personalized therapies available to all who need them? We need to bring standardized, industrial rigor to these deeply individual therapeutics.

The SCB’s Draft Report comment period is open until May 30. If you have questions or comments about the needs for standards, please send us a message. Thank you!

Amy DuRoss is the CEO and Co-founder of Vineti. If you’d like to learn more about how Vineti’s Personalized Therapy Management (PTM) is helping to standardize and industrialize workflows for personalized therapies, please contact us.