Standards efforts and landscape for rapid microbial testing methodologies in regenerative medicine

Area of Science:

• Regenerative Medicine
• Microbial Testing
• Standards Development

Background:

• Regenerative medicine product development faces delays due to slow microbial testing.
• Rapid microbial testing methods (RMTMs) are a high-priority industry need.
• The Standards Coordinating Body (SCB) addresses industry challenges through standards development.

Purpose of the Study:

• To describe SCB's efforts in developing standards for RMTMs in regenerative medicine.
• To outline the current landscape of RMTMs, including traditional and alternative methods.
• To present ongoing initiatives and challenges in RMTM implementation for product release.

Main Methods:

• Extensive stakeholder engagement, including surveys and workshops.
• Coordination of working groups and participation in standards development organizations.
• Development of documentary standards (ISO and ASTM) and microbial materials.

Main Results:

• Identified RMTMs as critical for timely regenerative medicine product release.
• Two documentary standards are under development for risk-based assay selection and sampling methods.
• Initiatives are underway to create microbial materials for inter-laboratory testing and method validation.

Conclusions:

• SCB is actively facilitating the development of RMTM standards to overcome industry challenges.
• Standardized RMTMs are essential for accelerating the commercialization of regenerative medicine products.
• Ongoing efforts aim to increase awareness, dialogue, and participation in regenerative medicine standards development.