SCB Updates Regenerative Medicine Standards Landscape Report
An updated version of the Regenerative Medicine Standards Landscape report, developed by SCB, is now available. The report provides a snapshot of the current landscape of regenerative medicine standards, outlining both existing and in-development standards.
Updated Features
This latest Fall 2020 update includes:
26 new standards
Expanded descriptions of 44 standards to help stakeholders assess the relevance of standards to their operations
Direct links to purchase or request access to all standards in the report
50 standards updated to reflect changes in title, publication status, or revision year
Icons to help users quickly find new or changed content
Leveraging the Report’s Resources to Improve Operations
The report has become the canonical resource for helping the regenerative medicine community identify the standards that can help improve product development operations. If incorporated early in the development process, standards can help save time and money by offering insight into efficient methodologies and practices and facilitate a smoother regulatory approval process for new therapies.
For example, employing the following three standards—all accessible through the SCB report—could help to more efficiently accomplish upstream processes:
ISO 20391-1, Cell Counting – Part 1: General Guidance on Cell Counting Methods
ISO 20391-2, Cell counting – Part 2: Experimental design and statistical analysis to quantify counting method performance
ISO/TS 20399, Ancillary materials present during the production of cellular therapeutic products
For more information on how standards can help facilitate innovation and product development, accelerate regulatory review of new products, and reduce costs, check out SCB’s guide to the benefits of standards.
Feedback Welcome
The Regenerative Medicine Standards Landscape is a living document designed to evolve as new standards relevant to regenerative medicine are developed. Feedback and input from the community is encouraged and welcomed and may include:
Suggestions on additional standards or SDOs to include
Corrections to existing standards or other report content
Any other suggestions for enhancing the report
Please contact SCB if you have feedback to help improve the report’s accuracy and completeness.
DIGITAL VERSION Coming Soon
To increase the usability of the report for the regenerative medicine community, SCB is developing a web-based, interactive version of the report, anticipated to be released in Spring 2021.