Project: Cell Collection Standards for Cell and Gene Therapies

Type: Standards Advancement Project

Partners: Parenteral Drug Association (PDA) and The SCB Cell Therapy, Gene Therapy, and Tissue Engineering Sector Working Groups

Description:

The collection of high-quality cells is a cornerstone of manufacturing safe, effective cell and gene therapy products. Because other advanced fields with similar biological products (e.g., bone marrow and apheresis) have established collection best practices, 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 that establishes consistent start- and end-of-collection procedures for apheresis centers conducting cell collection for regenerative medicine therapies.

Anticipated Availability: Early 2024

Progress:

(learn more about the standards advancement process)

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

Assembled a Working Group: SCB assembled a working group of more than 30 experts from academia, government, and industry that will draft the cell collection standard. The group developed 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.

Conducting a Feasibility Assessment: In December 2020, SCB organized a meeting of experts from multiple stakeholder groups to discuss barriers and opportunities for potential standard topics. SCB developed a feasibility report outlining the potential focus areas and next steps for a standard.

Submitted to PDA: The working group began drafting considerations and guidelines for cell collection for cell and gene therapies and submitted the standard to the Parenteral Drug Association (PDA) as a potential work item in February 2021; it was accepted as BSR/PDA Standard 08-202x, Apheresis Collection for Cell and Gene Therapy Products. SCB will coordinate the working group as it continues to draft the standard.

Get Engaged:

Please contact SCB to learn more about this initiative.