Project: Requirements for Cell Therapy Manufacturing Equipment
Type: STandards Advancement Project
Partners: ISO/TC 276 U.S. Working Group 4 (US WG4), National Institute of Standards and Technology (NIST), and the SCB Cell Therapy Sector and Tissue Engineering Sector Working Groups
Get Involved:Standard published: additional needs TBD
|
Description:
Variations in manufacturing equipment and processing techniques across regenerative medicine advanced therapies development make it difficult to evaluate and ensure consistent product quality and safety. Minimum technical and operational requirements and general considerations for cell therapy manufacturing systems—including hardware and software—will allow product developers to assess the impact of manufacturing changes or innovations on their products and will enable cross-comparison of products developed in different locations or by different companies.
SCB coordinated the U.S. effort to develop an ISO documentary standard that defines relevant cell therapy manufacturing terms, minimum equipment requirements, and general considerations for equipment involved in cell procurement, isolation/selection, expansion, washing and volume reduction, in-line monitoring, and cryopreservation.
This standard will apply to any unit operation system, whether used alone or in combination with other equipment. Exclusions from this document include cell processing equipment used at the point of care, analytical devices, biosafety cabinets, and software to control multiple equipment systems or multiple unit operations.
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Presented Draft Standard to ISO/TC 276: SCB submitted a draft standard as a work item for discussion at the June 2018 ISO/TC 276 meeting. This draft was recommended for ballot as a New Work Item Proposal (NWIP).
Solicited Comments Through ISO Ballot: The standard was approved as an official work item (ISO/TS 23565: General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use) and underwent several rounds of comment and revision.
Standard Published: This standard was published in October 2021.
Get Engaged:
SCB needs subject matter experts like you to review and contribute to the draft standard. To help, please contact SCB.