ASTM_F_3089_-_14.pdf

Designation:F308914Standard Guide forCharacterization and Standardization of PolymerizableCollagen-Based Products and Associated Collagen-CellInteractions1This standard is issued under the fixed designation F3089;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe collagen family of proteins represents the major structural and mechanical component of thein-vivo extracellular matrix of human tissues and organs.Type I collagen is the most abundant and assuch,it is an ideal candidate for medical materials,tissue-engineered medical products,delivery oftherapeutic cells/molecules,and in-vitro cell/tissue culture applications.Furthermore,it is now evidentthat specific collagen material properties,including microstructure,mechanical integrity(stiffness),cell adhesion,and biodegradation are major determinants of the interfacial properties between cellsand collagen-based materials,including guidance of fundamental cell behaviors that contribute torecapitulation and/or restoration of tissue structure and function.Advanced understanding of collagenself-assembly,as occurs in vivo and in vitro,is contributing to a rapid expansion of commercial andlaboratory-produced collagen formulations that polymerize(self-assemble)or exhibit solution to gel(matrix)transition.Most recent developments have focused on collagen polymer formulations withtunable features to support the rational design of collagen materials for improved tissue integration andguidance of cell fate.Unfortunately,the term“collagen”is applied generally to describe variouscollagen types and formulations(soluble,insoluble,monomeric,atelocollagen)that vary significantlyin their molecular compositions,self-assembly capacity and properties,and ability to interact withcells.As such,the need exists for an expanded set of characterization and standardization strategiesto facilitate comparison,safety and efficiency testing,and translation of the next generation collagenpolymer formulations and associated self-assembled collagen-based materials produced with theseformulations.1.Scope1.1 This guide for characterizing polymerizable collagens isintended to provide characteristics,properties,test methods,and standardization approaches for use by producers,manufacturers,and researchers to identify specific collagenpolymer formulations and associated self-assembled collagen-based products produced with these formulations.This guidewill focus on the characterization of polymer forms of Type Icollagen,which is the most abundant collagen in mammalianconnective tissues and organs,including skin,bone,tendon,and blood vessels.Type I collagen may be derived from avariety of sources including,but not limited to,animal orcadaveric tissues,cell culture,recombinant,and chemicalsynthesis.This guide is intended to focus on purified Type Icollagen polymers as a starting material for wound andhemostatic dressings,surgical implants,substrates for tissue-engineered medical products(TEMPs),delivery vehicles fortherapeutic cells or molecules,and 3D in-vitro tissue systemsfor basic research,drug development,and toxicity testing.Polymerizable or self-assembly implies that the collagen com-position exhibits spontaneous macromolecular assembly fromits components in the absence of the addition of exogenousfactors including cross-linking agents.Self-assembling colla-gen polymers may include,but are not limited to:(1)tissue-derived atelocollagens,monomers,and oligomers;(2)collagenproteins and peptides produced using recombinant technology;and(3)chemically synthesized collagen mimetic peptides.Itshould be noted that the format of associated self-assembledcollagen-based products also will vary and may include inject-able solutions that polymerize in situ as well as preformedsheets,particles,spheres,fibers,sponges,matrices/gels,coatings,films,and other forms.This guide may serve as a1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved May 1,2014.Published June 2014.DOI:10.1520/F3089-14.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 template for characterization and standardization of otherfibrillar collagen types that demonstrate polymerization orself-assembly.1.2 The ability of self-assembled collagen materials to guidecellular responses through provision of cellular adhesion andproteolytic domains as well as physical constraints(forexample,structural,cell-matrix traction force)has been welldocumented through extensive clinical(1,2)2and basic re-search studies(3,4).The biocompatibility and appropriatenessof use for a s