1、Designation: F3089 14Standard 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 adopt
2、ion 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 mecha
3、nical 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.
4、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 cel
5、l 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-ass
6、emble) 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 appli
7、ed 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 characteriz
8、ation 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 polymeriza
9、ble 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. T
10、his 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
11、 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 forthe
12、rapeutic 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 exogenousfacto
13、rs 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. Its
14、hould 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 a1T
15、his 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 Int
16、ernational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1template for characterization and standardization of otherfibrillar collagen types that demonstrate polymerization orself-assembly.1.2 The ability of self-assembled collagen materials to guidecellular res
17、ponses 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
18、 specific application(s) is the responsibility of theproduct manufacturer.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 WarningMercury has been designated by the Envi-ronmental Protection Agency (EPA) and many state ag
19、enciesas a hazardous material that can cause central nervous system,kidney, and liver damage. Mercury, or its vapor, may behazardous to health and corrosive to materials. Caution shouldbe taken when handling mercury and mercury-containingproducts. See the applicable product Material Safety DataSheet
20、 (MSDS) for details and the EPA website (http:/www.epa.gov/mercury/faq.htm) for additional information. Us-ers should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibitedby state law.1.5 The following precautionary caveat pertains only to thetest met
21、hod portion, Section 5, of this guide. This standarddoes not purport to address all of the safety concerns, if any,associated with its use. It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory limitatio
22、ns priorto use.2. Referenced Documents2.1 ASTM Standards:3E1298 Guide for Determination of Purity, Impurities, andContaminants in Biological Drug ProductsF619 Practice for Extraction of Medical PlasticsF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization TestF748 Practi
23、ce for Selecting Generic Biological Test Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice
24、for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1251 Terminolo
25、gy Relating to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)4F1439 Guide for Performance of Lifetime Bioassay for theTumorigenic Potential of Implant MaterialsF1903 Practice for Testing For Biological Responses toParticles In VitroF1904 Practice for Testing the Biological Re
26、sponses toParticles in vivoF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity (With-drawn 2011)4F1906 Practice for Evaluation of Immune Responses InBiocompatibility Testing Using ELISATests, LymphocyteProliferation, and Cell Migration (Withdrawn 201
27、1)4F1983 Practice for Assessment of Compatibility ofAbsorbable/Resorbable Biomaterials for Implant Applica-tionsF2148 Practice for Evaluation of Delayed Contact Hyper-sensitivity Using the Murine Local Lymph Node Assay(LLNA)2.2 ISO Standards:5ISO 109931 Biological Evaluation of Medical DevicesPart 1
28、: Evaluation and Testing with a Risk ManagementProcessISO 109933 Tests for Genotoxicity, Carcinogenicity andReproductive ToxicityISO 109939 Framework for Identification and Quantifica-tion of Potential Degradation ProductsISO 1099310 Biological Evaluation of Medical DevicesPart 10: Tests for Irritat
29、ion and Delayed-Type Hypersen-sitivityISO 1099317 Methods for Establishment of AllowableLimits for Leachable Substances Using Health-BasedRisk AssessmentISO 134081 Aseptic Processing of Health Care ProductsPart 1: General RequirementsISO 14971 Medical DevicesApplication of Risk Manage-ment to Medica
30、l DevicesISO 224421 Animal Tissues and their Derivatives Utilizedin the Manufacture of Medical DevicesPart 1: Analysisand Management of RiskISO 224422 Animal Tissues and their Derivatives Utilizedin the Manufacture of Medical DevicesPart 2: Controlson Sourcing, Collection, and HandlingISO 224423 Ani
31、mal Tissues and their Derivatives Utilizedin the Manufacture of Medical DevicesPart 3: Valida-tion and the Elimination and/or Inactivation of Virus andTransmissable Agents2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced ASTM standards, v
32、isit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.5Available
33、 from International Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http:/www.iso.org.F3089 1422.3 U.S. and European Pharmacopeia Documents:6United States Pharmacopeia (USP), Edition XXX (30)USP 30/NF 19 Viral Safety Evaluation of Biotechnology
34、Products Derived from Cell Lines of Human or AnimalOriginEuropean Pharmacopeia 5.02.4 Code of Federal Regulations:721 CFR 312 Investigational New Drug Application21 CFR Part 820 Quality System RegulationFederal Register Vol. 43 No. 141, Friday, July 21, 197821 CFR Parts 207, 807, and 1271 Human Cell
35、s, Tissues andCellular and Tissue-Based Products, Establishment Reg-istration and ListingFederal Register, Vol. 66 No. 13, Jan. 19, 2001/Rules andRegulations, p. 5447Federal Register, Vol. 72 No. 8, Jan. 12, 2007, pp.15811619, Proposed Rule: Use of Materials Derivedfrom Cattle in Medical Products In
36、tended for Use inHumans and Drugs Intended for Use in Ruminants21 CFR Part 1271, Part C Suitability Determination forDonors of Human Cell and Tissue-based Products, Pro-posed RuleCurrent Good Tissue Practice for Manufacturers of HumanCellular and Tissue-Based Products Inspection and En-forcement. Pr
37、oposed Rule. Federal Register/Vol. 66, No.5/January 8, 2001/Proposed Rules, pp. 1552-1559Guidance for Screening and Testing of Donors of HumanTissue Intended for Transplantation Availability. FederalRegister/Vol. 62, No. 145/July 29, 1997/Notices DraftGuidance for Preclinical and Clinical Investigat
38、ions ofUrethral Bulking Agents used in the Treatment of UrinaryIncontinence. November 29, 1995. (ODE/DRARD/ULDB), Document No. 850Guidance for Industry and for FDA Reviewers MedicalDevices Containing Materials Derived from AnimalSources (Except for In Vitro Diagnostic Devices), Novem-ber 6, 1998, U.
39、S. Department of Health and HumanServices, Food and Drug Administration, Center for De-vices and Radiological HealthCFR 610.13(b) Rabbit Pyrogen Assay2.5 ICH Documents:8ICH M3 Guidance for Industry M3 Nonclinical SafetyStudies for the Conduct of Human Clinical Trials forPharmaceuticals 62 FR 62922 (
40、1997)ICH S2A Guideline for Industry S2A Specific Aspects ofRegulatory Genotoxicity Tests for Pharmaceuticals 61 FR18199 (1996)ICH S2B Guidance for Industry S2B Genotoxicity: A Stan-dard Battery for Genotoxicity Testing of Pharmaceuticals62 FR 62472 (1997)ICH S5A Guideline for Industry S5A Detection
41、of Toxicityto Reproduction for Medicinal Products 59 FR 48746(1994)ICH S5B Guidance for Industry S5B Detection of Toxicityto Reproduction for Medicinal Products: Addendum onToxicity to Male Fertility 61 FR 15360 (1996)ICH S1A Guideline for Industry S1A The Need for Long-term Rodent Carcinogenicity S
42、tudies of Pharmaceuticals61 FR 8153 (1996)ICH S1B Guidance for Industry S1B Testing for Carcinoge-nicity of Pharmaceuticals 63 FR 8983 (1998)ICH S1C Guideline for Industry S1C Dose Selection forCarcinogenicity Studies of Pharmaceuticals 60 FR 11278(1995)ICH S1C(R) Guidance for Industry Addendum to D
43、oseSelection for Carcinogenicity Studies of Pharmaceuticals:Addition of a Limit Dose and Related Notes 62 FR 64259(1997)ICH Q1A ICH Harmonized Tripartite Guidance for StabilityTesting of New Drug Substances and Products (September23, 1994)2.6 FDA Documents:9U.S. Food and Drug Administration (FDA and
44、 Committeefor Proprietary Medicinal Products (CPMP), 1998 Inter-national Conference on Harmonization (ICH), Quality ofBiotechnological Products: Viral Safety Evaluation ofBiotechnology Products Derived from Cell Lines of Hu-man or Animal Origin, Consensus Guideline ICH ViralSafety Document: Step 5FD
45、A Guidance for Industry Pyrogen and Endotoxins Test-ing: Questions and Answers, DHHS, June 2012U.S. Food and Drug Administration (FDA) Center forBiologics Evaluation and Research (CBER), 1993 Pointsto Consider in the Characterization of Cell Lines Used toProduce BiologicalsU.S. Food and Drug Adminis
46、tration (FDA) Center forBiologics Evaluation and Research (CBER), 1997 Pointsto Consider in the Manufacture and Testing of MonoclonalAntibody Products for Human Use, 94D-0259FDA Interim Guidance for Human and Veterinary DrugProducts and Biologicals, Kinetic LAL techniques,DHHS, July 15, 19912.7 AAMI
47、 Documents:10ANSI/AAMI/ISO 11737-1: 2006 Sterilization of MedicalDevicesMicrobiological MethodsPart 1: Estimationof Bioburden on ProductANSI/AAMI/ISO 11737-2: 1998 Sterilization of MedicalDevicesMicrobiological MethodsPart 2: Tests of Ste-rility Performed in the Validation of a Sterilization Process
48、AAMI TIR No. 19-1998 Guidance for ANSI/AAMI/ISO10993-7: 1995, Biological Evaluation of MedicalDevicesPart 7: Ethylene Oxide Sterilization Residuals6Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.7Available from U.S. Government Printing Offic
49、e Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.8Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use (ICH), ICHSecretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,Switzerland, http:/www.ich.org.9Available from Food and Drug Administration (FDA), 10903 New HampshireAve., Silver Spring, MD 20993-0002, http:/www.fda.gov.10Available from Association for the Advancement of Medical Instrumentat
