Notes:
Cover TEMPS and their components; interaction of the product
with the host; Assay for products produced either by host or against host
Morphology: size, shape, granularity, degree of ruffling
(activation). Technology can be used in combination with other assay
techniques.
Inflammatory Products:
Complement & Ig activation against TEMPS or components
(i.e., encapsulated Islet cells for insulin production). ASTM: Standard
Practice for Testing for Whole Complement Activation in Serum by Solid
Materials
CL to test for ROS in the presence of alginate-, chitosan- or
collagen-based products. Std for characterizing Alginate, Chitosan &
Collagen under development in ASTM.
Cellular Adhesion Assay: Cross-cutting assay method to test
for wanted or unwanted adhesion to TEMPS or their components.
Receptor analysis: Usually fluorescence staining techniques
which can be used in combination with morphological & cellular adhesion
assays. Purpose is to determine the presence of a receptor and if receptor is
upregulated.
Additionally, does receptor function as expected under
conditions of TEMP Use? ASTM TEMPS subcommittees on Normal Biological Function
of cardiovascular and bone
Bioactive Molecules: Bone Morphogenetic Proteins. Std for
assay of BMP activity under ballot at TEMPS.
Gene Products: Phenotypic expression. Is gene activity proper
for expected function? Assessment, Clinical Trials, Microbiol Safety &
Adven. Agents.
