Project: Cell Collection Standards for Cell Therapies

Type: Standards Advancement Project

Partners: Be the Match Biotherapies, Novartis, Celgene, ISO/TC 276 U.S. Working Group 4 (US WG4)

Description:

The collection of high-quality cells is the cornerstone to manufacturing safe, effective cell therapy products. Because other advanced fields with similar biological products have established collection best practices (e.g., bone marrow and apheresis), the regenerative medicine community is eager to leverage those practices to create an international collection process standard that will help ensure the consistency of the critical quality attributes of cells collected for regenerative medicine products.

At the request of industry stakeholders, SCB is working with ISO/TC 276 WG4 to coordinate development of an international standard on cell collection processes—including documentation, record-retention, collection protocols, disposables, and collection equipment—for cell-based therapeutics.

Progress:

Hosted a Workshop: SCB hosted a workshop for interested stakeholders at the University of Pennsylvania on September 13, 2018, with input and discussion focused on the areas of need that should be included in this standard.

Develop a Working Group: SCB has begun the development and coordination of a working group that will draft the standard for this topic.

Present this Topic: SCB will present this topic as a possible new work item to ISO/TC 276 WG4 at the December 2018 meeting in Potsdam, Germany.

Provide Drafting Support: SCB will support the working group as it develops an international standard in ISO/TC 276 WG4.

Get Engaged:

SCB needs subject matter experts like you to join the working group and contribute to the draft. To help, please contact SCB’s Senior Technical Program Manager Dawn Henke at dhenke@regenmedscb.org.