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Standard Being Developed for NIST Tissue Engineering Scaffolds.

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February 8, 2013 - Proposed ASTM standard, ASTM WK39698, Test Method: Using NIST Tissue Engineering Reference Scaffolds for Cell Culture Tests, will provide users with specific protocol for measuring cell adhesion and proliferation in scaffold using NIST reference scaffolds as controls. Once approved, this proposed standard will be used in combination with RM8394 NIST Reference Material scaffolds for cell culture as stable, reproducible 3D scaffold substrate for controls in scaffold development.

Proposed ASTM Standard for NIST Tissue Engineering Reference Scaffolds Being Developed

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ASTM International
100 Barr Harbor Dr., Box C700
West Conshohocken, PA, 19428-2959

Press release date: January 31, 2013

W. CONSHOHOCKEN, Pa.–There has long been a need within the tissue engineering/regenerative medicine sector for three-dimensional reference scaffolds to serve as physical standards for the materials that are used as beds for the growth of cell cultures. The National Institute of Standards and Technology has created such references, which will eventually be accompanied by a proposed ASTM International standard that will provide instruction for use of the NIST scaffolds in cell culture testing.

The proposed ASTM standard, ASTM WK39698, Test Method: Using NIST Tissue Engineering Reference Scaffolds for Cell Culture Tests, is being developed by Subcommittee F04.42 on Biomaterials and Biomolecules for TEMPs, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

Once approved, the proposed standard will be used hand-in-hand with the RM8394 NIST Reference Material scaffolds for cell culture (to be released in April 2013) as a stable, reproducible three-dimensional scaffold substrate for controls in scaffold development.

The proposed standard will provide users (including tissue engineers, those using 3-D for drug screening and in vitro disease models) with a very specific protocol for measuring cell adhesion and proliferation in a scaffold, using the NIST reference scaffolds as controls.

“Culture in 3-D scaffolds is much harder than on traditional flat culture dishes,” says Carl G. Simon Jr., Ph.D., a NIST biologist and F04 member. “Seeding cells onto 3-D scaffolds is more difficult due to their porous nature and because they are not attached to well bottoms.”

Simon notes other difficulties that make it challenging to get consistent results when testing 3-D scaffolds:
• Proliferation can be uneven due to uneven seeding and 3-D transport of nutrients and waste;
• Getting cells out of scaffolds due to pores can be hard, making it difficult to measure cell state; and
• Imaging cells is more difficult since scaffolds are opaque and the surfaces are uneven.

For all of these reasons, the NIST scaffolds and accompanying ASTM standard will serve as benchmarks for comparison to unknowns and enable interlaboratory comparisons.

All parties with an interest in 3-D cell culture are invited to join in the development of ASTM WK39698.

To purchase ASTM standards, visit and search by the standard designation, or contact ASTM Customer Relations (phone: 877-909-ASTM; ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit .

ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

For more news in this sector, visit or follow us on Twitter @ASTMMedical.

ASTM Committee F04 Next Meeting: May 21-24, 2013, May Committee Week, Indianapolis, Ind.
Technical Contact: Carl G. Simon Jr., Ph.D., Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-8574;

ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720;
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603;
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