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Collagen-Based Medical Products Are Subjects of Proposed New ASTM Standard


A proposed new ASTM International standard will be used in the design, development, quality control and comparison of a variety of collagen-based medical products, including surgical implants, delivery vehicles for therapeutic cells or molecules and substrates for tissue engineered medical products. ASTM WK43011, Specification for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions, is currently 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.

In addition to product development, the proposed standard will be valuable as a research tool, according to Sherry Voytik-Harbin, Ph.D., associate professor of biomedical engineering and basic medical sciences, Weldon School of Biomedical Engineering, Purdue University.

“Such collagen formulations have the capability in basic research where they can be applied as tunable three-dimensional (3D) substrates to support the culture of cells and tissues in vitro,” says Voytik-Harbin. “New collagen polymer formulations, together with advancements in the characterization and standardization of their molecular and physical properties and cell-instructive capacity, will fuel development of new generation research tools (3D in-vitro tissue models), drug/molecular delivery systems and regenerative medicine solutions.”

Tetsuro Wakatsuki, Ph.D., chief scientific officer, InvivoSciences Inc., has been addressing needs for a standard characterizing various properties of collagen products and how they interact with cells and can be modified and remodeled by cells. “Our bioengineers tested almost all of the commercially available polymerizable collagen products, but none of them exhibited the same properties, including mechanical properties of engineered tissues fabricated with them,” Wakatsuki says. “We hope that the new standard will facilitate improving quality control processes in tissue engineering product development.”

ASTM WK43011 will address issues related to production, characterization and functional testing of polymerizable collagens for research and clinical applications, as well as product development and quality control. Collagens exhibiting polymerization or self-assembly are currently further categorized as tissue-derived (atelocollagen, gelatin, monomer and oligomer), recombinant (collagen proteins and peptides) and chemically synthesized (collagen mimetic peptides).

Once it has been approved, the proposed standard will be used primarily by laboratories and commercial entities that manufacture and use collagen for development of research and medical products. Regulatory bodies may also consider ASTM WK43011 for comparing the composition, functional properties and safety of collagen-based products.

ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit

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ASTM Committee F04 Next Meeting: Nov. 12-14, 2013, November Committee Week, Jacksonville, Fla.
Technical Contact: Sherry Voytik-Harbin, Weldon School of Biomedical Engineering and Department of Basic Medical Sciences, Purdue University, Phone: 765-496-6128;; Tetsuro Wakatsuki, InvivoSciences Inc., Phone: 608-713-0149; 
ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720;
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603;

Release #9490

October 23, 2013

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