Curated Standards Packages

SCB has teamed up with the American National Standards Institute (ANSI) to create standards packages tailored to specific regenerative medicine application areas.

Additionally, SCB has curated packages of standards recognized by FDA through the CBER voluntary consensus standards recognition program.

1. CBER Voluntary Consensus Standards Recognized: Scaffolds

2. CBER Voluntary Consensus Standards Recognized: Sequencing

3. CBER Voluntary Consensus Standards Recognized: Cell Characterization

4. CBER Voluntary Consensus Standards Recognized: Cryopreservation and Storage

5. Tissue Engineering Standards Addressing Product Quality and Characterization

6. Cell Therapy Standards Addressing Product Quality and Characterization

   • Packages 5 and 6 feature 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.

7. Tissue Engineering Standards Addressing Analytical and Testing Methodologies

   • Package 7 includes standards 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)

Bundled Standards at a Discounted Rate

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

ANSI Standards Packages in the Regenerative Medicine Standards Portal

SCB’s Regenerative Medicine Standards Portal now allows you to easily filter standards by their inclusion in these ANSI packages.

COMING SOON: More 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, focused on specific applications to help guide users through an entire process.

If there is a group of 4+ ANSI standards that you’d like to suggest as a new bundle, please contact SCB.