Project: Standard guide for risk-based approaches to controlling particulate matter in the manufacturing of regenerative medicine products
Type: Standards Advancement Project
Partners: ASTM F04 AND THE SCB Cell and Gene THERAPY SECTOR WORKING GROUP
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Description:
Regenerative medicine and advanced therapy products and manufacturing processes present unique challenges for controlling particulate matter as compared to typical biological products. A lifecycle approach to particulate contamination control of regenerative medicine products should consider the contamination risks, controls, detection/identification methods, and process improvements implemented during product development, manufacturing, inspection, and storage.
Knowledge gained through manufacturing experience and product analysis is used to reduce the particulate contamination risk and improve particle control through enhanced preventative and inspectional processes.
This SCB working group is drafting a standard to addresses considerations for the development of particulate control strategies, including product life cycle management, detection/inspection, and mitigation strategies. This standard will include specific analytical methods for particle detection, particle classification, the development of a particulate library, and the determination of acceptable particle limits.
ANTICIPATED AVAILABILITY: January 2027
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.
Assembled a Particulates in Regenerative Medicine Products Working Group: SCB has established a working group for this effort and initiated a biweekly working group meetings to coordinate the standard advancement effort.
Conducted Feasibility Assessment: In July 2024, SCB organized a meeting of 17 experts from multiple stakeholder groups to discuss barriers and opportunities for potential Particulates in Regenerative Medicine Products standard topics. SCB developed a feasibility report on the assessment outcomes and planned next steps.
Begin Drafting Standard: SCB presented the standard to ASTM in November 2024. SCB will coordinate the working group as it drafts the standard.
Get Engaged:
To join the working group or learn more about this initiative, please compete this survey or contact SCB.