Project: Cell Collection Standards for Cell Therapies

Type: Standards Advancement Project

Partners: The SCB Cell Therapy and Tissue Engineering Sector Working Groups

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 to coordinate development of a standard on cell collection processes—including documentation, record-retention, collection protocols, disposables, and collection equipment—for cell-based therapeutics.

Anticipated Availability: 2021-2025

Progress:

Chart of project phases, steps, and anticipated completion dates

Note: Projected dates are estimates only. Development of a standard depends on SDO timelines, which can vary.

Hosted a Workshop: SCB hosted a workshop for more than 35 interested stakeholders at the University of Pennsylvania in September 2018, during which input and discussion focused on the areas of need that should be included in this standard.

Developed a Working Group: SCB coordinated the development of a working group of more than 30 experts from academia, government, and industry that will draft the standard for this topic. Currently, the group is drafting a survey for industry to determine commonalities in cell collection protocols and processes and to assess the aspects of the collection process that can be standardized.

Provide Drafting Support: SCB will coordinate the working group as it gathers information and develops a draft standard.

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.