Designation:F3089−14StandardGuideforCharacterizationandStandardizationofPolymerizableCollagen-BasedProductsandAssociatedCollagen-CellInteractions1ThisstandardisissuedunderthefixeddesignationF3089;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONThecollagenfamilyofproteinsrepresentsthemajorstructuralandmechanicalcomponentofthein-vivoextracellularmatrixofhumantissuesandorgans.TypeIcollagenisthemostabundantandassuch,itisanidealcandidateformedicalmaterials,tissue-engineeredmedicalproducts,deliveryoftherapeuticcells/molecules,andin-vitrocell/tissuecultureapplications.Furthermore,itisnowevidentthatspecificcollagenmaterialproperties,includingmicrostructure,mechanicalintegrity(stiffness),celladhesion,andbiodegradationaremajordeterminantsoftheinterfacialpropertiesbetweencellsandcollagen-basedmaterials,includingguidanceoffundamentalcellbehaviorsthatcontributetorecapitulationand/orrestorationoftissuestructureandfunction.Advancedunderstandingofcollagenself-assembly,asoccursinvivoandinvitro,iscontributingtoarapidexpansionofcommercialandlaboratory-producedcollagenformulationsthatpolymerize(self-assemble)orexhibitsolutiontogel(matrix)transition.Mostrecentdevelopmentshavefocusedoncollagenpolymerformulationswithtunablefeaturestosupporttherationaldesignofcollagenmaterialsforimprovedtissueintegrationandguidanceofcellfate.Unfortunately,theterm“collagen”isappliedgenerallytodescribevariouscollagentypesandformulations(soluble,insoluble,monomeric,atelocollagen)thatvarysignificantlyintheirmolecularcompositions,self-assemblycapacityandproperties,andabilitytointeractwithcells.Assuch,theneedexistsforanexpandedsetofcharacterizationandstandardizationstrategiestofacilitatecomparison,safetyandefficiencytesting,andtranslationofthenextgenerationcollagenpolymerformulationsandass...
