SCB and ANSI Develop Curated Standards Packages
A concern SCB often hears from regenerative medicine stakeholders is that it can be difficult to find standards that are relevant to their work processes. To address this challenge, SCB teamed up with the American National Standards Institute (ANSI) to develop standards packages tailored to specific regenerative medicine application areas.
Bundled Standards at a Discounted Rate
Each package bundles existing ANSI-accredited standards from multiple standards developing organizations (SDOs) relevant to a specific application area and offers them at a discounted rate. The initial standards packages curated by SCB include standards from ASTM, ISO, and PDA.
The packages aim to make it faster and easier for regenerative medicine product developers to identify standards that can help:
Save time and money by offering insight into efficient methodologies and practices
Improve the safety, consistency, and comparability of regenerative medicine products
Facilitate a smoother regulatory approval process for new therapies
SCB has curated three standards packages so far, with more planned for other application areas.
1) Tissue Engineering Standards Addressing Product Quality and Characterization
2) Cell Therapy Standards Addressing Product Quality and Characterization
Packages 1 and 2 include standards focused on defining quality attributes (e.g., identity, quantity, purity, sterility, biological activity/potency) of materials used in regenerative medicine therapies and providing a clear understanding of their intended use. They provide information on topics such as:
Establishing a quality management system
Designing measurements with sufficient selectivity, sensitivity, resolution, and robustness to enable subsequent decision making
3) Tissue Engineering Standards Addressing Analytical and Testing Methodologies
Package 3 includes standards for tissue engineering products focused on methodologies used to detect, measure, and/or monitor certain attributes of a material and the state in which it is located (e.g., evaluating printability of bioinks or measuring properties of scaffolds).
What’s Next: ADDITIONAL Standards Packages
SCB plans to continue developing more standards packages in collaboration with ANSI. In addition to the large, broad packages that cover several methods with varying applications, SCB also plans to create smaller, more targeted packages. These targeted packages will focus on specific applications and will help to guide users through the entirety of a process.
If you have requests, feedback, or suggestions for new standards packages, please contact SCB.
Discover More Standards Relevant to Your Organization
SCB’s Regenerative Medicine Standards Portal allows you to easily filter standards by applicable sector, functional area, and standards developing organization, as well as search using specific keywords.