Gels made with alginate--a polysaccharide polymer from seaweed.
Standards Come to ASTM
In the field of biomedicine, 37 new standards are under development
by ASTM Committee F04 on Medical and Surgical Materials and Devices, Division IV on
Tissue Engineered Medical Products. They cover tissue-engineered
medical products and their components used in biomedical and pharmaceutical
industriesthe broadest focus in the field of regenerative medicine
at this time, according to Division IV Vice-Chair Grace Lee Picciolo,
Ph.D., a cellular biologist with the U.S. Food and Drug Administration,
Center for Devices and Radiological Health, Office of Science
and Technology, Rockville, Md.
Tissue engineering involves cell and tissue repair and regeneration,
Picciolo says, by providing scaffolds as substrates and bioactive
molecules as signals to the cells. She comments about a recent
news report on the reconstruction of a frostbitten nose: Tissue
engineering has enabled this type of shaping of the repaired tissue.
Engineered living cellular constructs can result in the controlled
replacement of damaged or lost tissue, she confirms.
Division IV on Tissue Engineered Medical Products was formed in
1997 and has had from 85 to 130 members involved in meetings and
activities. Weve progressed to establish a structure for our
division that includes 10 subcommittees, and 37 task groups,
says Picciolo, who with colleagues brought a focus on tissue engineering
to the FDA in 1994, and subsequently joined ASTM to develop standards.
Tissue engineering was a newly developing field in the biomedical
research and development arena. It became obvious that when biological
cells could be made to respond to materialsto use the materials
as a support and reservoir of signaling molecules and propagatethe
development of medical applications would follow. Thus, we saw
the need for standards for product development and regulatory
The Center for Devices and Radiological Health had previously
been closely allied with ASTM Committee F04 through their medical
devices standards. So it was suggested that we should approach
ASTM when we were looking for a standards organization that had
a process in place, avers Picciolo.
The divisions documentation of the use of important components
for tissue-engineered medical products has progressed steadily.
Two companies in the alginate field, one from Norway and one
from the United States, have contributed their research and expertise
to the ASTM standards effort, Picciolo notes. They have produced
purified alginates from marine seaweed since the 1990s. Jump-started
by this information, the Alginate Task Group, co-chaired by Dr.
Michael Dornish, is finalizing an alginate standard, and moving
on to one for chitosan.
Alginate is used in final products for drug delivery, via encapsulated
cells or bioactive substances, impression materials for dental
applications, and as a bulking aid to help prevent urinary incontinence,
explains David Kaplan, Ph.D., a microbiologist/cell biologist
also with the FDA OST and task group co-chair.
Among many drafts, Division IV has an approved standard and two
drafts near completion:
F 2027, Guide for Characterization and Testing of Substrate Materials
for Tissue Engineered Medical Products;
Draft Standard Guide for the Characterization and Testing of
Alginates as Starting Materials Intended for Use in Biomedical
and Tissue Engineered Medical Products Applications; and
Draft Standard Test Method for In Vitro Biological Activity
of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using
the W-20 Mouse Stromal Cell Line.
For further technical information, contact Grace Lee Picciolo, FDA CDRH, OST (301/827-4755), David Kaplan FDA, CDRH, OST (301/827-4754) or Michael Dornish, ProNova BioMedical, Gaustadalleen 21, Oslo N0371, Norway (472/295-8650).
Committee F04 meets Nov. 15-17 in Orlando, Fla. For meeting or
membership details, contact Staff Manager Teresa Cendrowska, ASTM (610/832-9718). //
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