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ASTM F3504-21

(Practice)

Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method

Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method

SIGNIFICANCE AND USE
5.1 In-vitro cell proliferation assays are used to screen the capability of cells to proliferate and self-renew within scaffolds for regenerative medicine and tissue-engineering applications. The cell proliferation in vitro, in conjunction with other characteristics of the cells such as gene expression, can be used to determine if the cells have maintained their properties.  
5.2 Cell proliferation may be an important parameter to test as a quality attribute of a cell-scaffold construct. This test helps to assess cell colonization within a scaffold.  
5.3 This method provides a technique for vital assessment and quantification of the fluorescence intensity related to dye metabolism by living and proliferating cells. This method assumes that viable cells will have an active metabolism, which is required to support life-associated cellular processes such as the conversion of nutrient sources into energy and proliferation. There may be cells that are not actively proliferating, yet are still viable within the construct. The methods described within this practice enable nondestructive testing for monitoring the cell proliferation kinetics throughout the culture period by repeated analysis at multiple time points on the same test sample with minimal toxicity. This standard practice is written only for resazurin dye, a non-cytotoxic reagent that should not affect cell viability and proliferation at low concentration. This is a distinct advantage over many other reagents used to measure cell number, such as measurements of the intracellular components (such as DNA, protease, or ATP) which require cell lysis and can therefore only be used for endpoint analysis.  
5.4 Resazurin, which has low fluorescence, may be metabolized by cells into resorufin, which is highly fluorescent. An increase in fluorescence caused by the conversion to resorufin may correlate with increased dehydrogenase activity, which may correlate with an increase in cell number and therefore proliferatio...
SCOPE
1.1 This practice describes how to conduct a nondestructive proliferation test for mammalian cells based on metabolic activity that can be used to assess the number of viable cells within three-dimensional (3D) scaffolds for regenerative medicine and in tissue-engineered medical products (TEMPs).  
1.2 This practice provides a detailed explanation of the resazurin cell metabolic activity method in terms of reagent concentrations, incubation times, cell culture media composition, calibration curve, controls, assay linearity, and limitations of the assay.  
1.3 This practice describes factors that can interfere with accurate cell proliferation assessment.  
1.4 Since the assay has washing steps, it is limited to assessing cells that are immobilized, such as by adhesion to a culture dish, adhesion to a scaffold, or encapsulation in a hydrogel.  
1.5 The assay is limited to cell types that can metabolize resazurin to provide a signal in the assay.  
1.6 This document does not propose acceptance criteria for a cell-based product based on the application of a cell proliferation test method.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
30-Sep-2021
ICS
07.100.99 - Other standards related to microbiology
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.43 - Cells and Tissue Engineered Constructs for TEMPs
Current Stage
Ref Project

Relations

Refers
ASTM F2312-11(2020) - Standard Terminology Relating to Tissue Engineered Medical Products
Effective Date
01-Feb-2020

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ASTM F3504-21 - Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive MethodASTM F3504-21 - Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
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ASTM F3504-21 - Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3504 − 21
Standard Practice for
Quantifying Cell Proliferation in 3D Scaffolds by a
1
Nondestructive Method
This standard is issued under the fixed designation F3504; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This practice describes how to conduct a nondestructive
F2312Terminology Relating to Tissue Engineered Medical
proliferation test for mammalian cells based on metabolic
Products
activity that can be used to assess the number of viable cells
F2664Guide for Assessing the Attachment of Cells to
withinthree-dimensional(3D)scaffoldsforregenerativemedi-
Biomaterial Surfaces by Physical Methods
cine and in tissue-engineered medical products (TEMPs).
F2739Guide for Quantifying Cell Viability and Related
1.2 This practice provides a detailed explanation of the
Attributes within Biomaterial Scaffolds
resazurin cell metabolic activity method in terms of reagent
F3163Guide for Classification of Cellular and/or Tissue-
concentrations, incubation times, cell culture media
Based Products (CTPs) for Skin Wounds
composition, calibration curve, controls, assay linearity, and
F3294Guide for Performing Quantitative Fluorescence In-
limitations of the assay.
tensity Measurements in Cell-based Assays with Wide-
field Epifluorescence Microscopy
1.3 This practice describes factors that can interfere with
3
2.2 ISO Standard:
accurate cell proliferation assessment.
ISO 10993Biological Evaluation of Medical Devices
1.4 Since the assay has washing steps, it is limited to
2.3 ASTM Adjuncts:
assessing cells that are immobilized, such as by adhesion to a 4
Digital Spreadsheet File
culture dish, adhesion to a scaffold, or encapsulation in a
hydrogel.
3. Terminology
1.5 The assay is limited to cell types that can metabolize 3.1 Definitions:
resazurin to provide a signal in the assay. 3.1.1 Unlessprovidedotherwisein3.2,terminologyshallbe
in conformance with Terminology F2312.
1.6 This document does not propose acceptance criteria for
3.1.2 non-viable cell, n—a cell not meeting one or more of
a cell-based product based on the application of a cell
the criteria for viability given in 3.1.6. F2739
proliferation test method.
3.1.3 proliferation competent cell, n—cell capable of
1.7 This standard does not purport to address all of the
replication. F3163
safety concerns, if any, associated with its use. It is the
3.1.4 senescence, n—invertebratecellcultures,theproperty
responsibility of the user of this standard to establish appro-
attributable to finite cell cultures, namely, their inability to
priate safety, health, and environmental practices and deter-
grow beyond a finite number of population doublings. Neither
mine the applicability of regulatory limitations prior to use.
invertebrate nor plant cell cultures exhibit this property. This
1.8 This international standard was developed in accor-
term is synonymous with in vitro senescence. F2664
dance with internationally recognized principles on standard-
3.1.5 stem cell, n—progenitor cell capable of self-
ization established in the Decision on Principles for the
replication, proliferation, and differentiation to produce cells
Development of International Standards, Guides and Recom-
that take on more specialized functions. F2312
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.43 on Cells and Tissue Engineered Constructs for TEMPs. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Oct. 1, 2021. Published November 2021. DOI: Available from ASTM International Headquarters. Order Adjunct No.
10.1520/F3504-21. ADJF3504-EA.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3504 − 21
3.1.6 viable cell, n—acellcapableofmetabolicactivitythat methods described within this practice enable nondestructive
...

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5.1 Terrestrial phytotoxicity tests are useful in assessing the effects of environmental samples or specific chemicals as a part of an ecological risk assessment (3-6, 12, 13).  
5.2 Though inferences regarding higher-order ecological effects (population, community, or landscape) may be made from the results, these tests evaluate responses of individuals of one or more plant species to the test substance.  
5.3 This guide is applicable for: (a) establishing phytotoxicity of organic and inorganic substances; (b) determining the phytotoxicity of environmental samples; (c) determining the phytotoxicity of sludges and hazardous wastes, (d) assessing the impact of discharge of toxicants to land, and (e) assessing the effectiveness of remediation efforts.
SCOPE
1.1 This guide covers practices for conducting plant toxicity tests using terrestrial plant species to determine effects of test substances on plant growth and development. Specific test procedures are presented in accompanying annexes.  
1.2 Terrestrial plants are vital components of ecological landscapes. The populations and communities of plants influence the distribution and abundance of wildlife. Obviously, plants are the central focus of agriculture, forestry, and rangelands. Toxicity tests conducted under the guidelines and annexes presented herein can provide critical information regarding the effects of chemicals on the establishment and maintenance of terrestrial plant communities.  
1.3 Toxic substances that prevent or reduce seed germination can have immediate and large impacts to crops. In natural systems, many desired species may be sensitive, while other species are tolerant. Such selective pressure can result in changes in species diversity, population dynamics, and community structure that may be considered undesirable. Similarly, toxic substances may impair the growth and development of seedlings resulting in decreased plant populations, decreased competitive abilities, reduced reproductive capacity, and lowered crop yield. For the purposes of this guide, test substances include pesticides, industrial chemicals, sludges, metals or metalloids, and hazardous wastes that could be added to soil. It also includes environmental samples that may have had any of these test substances incorporated into soil.  
1.4 Terrestrial plants range from annuals, capable of completing a life-cycle in as little as a few weeks, to long-lived perennials that grow and reproduce for several hundreds of years. Procedures to evaluate chemical effects on plants range from short-term measures of physiological responses (for example, chlorophyll fluorescence) to field studies of trees over several years. Research and development of standardized plant tests have emphasized three categories of tests: (1) short-term, physiological endpoints (that is, biomarkers); (2) short-term tests conducted during the early stages of plant growth with several endpoints related to survival, growth, and development; and (3) life-cycle toxicity tests that emphasize reproductive success.  
1.5 This guide is arranged by sections as follows:  
Section  
Title  
1  
Scope  
2  
Referenced Documents  
3  
Terminology  
4  
Summary of Phytotoxicity Tests  
5  
Significance and Use  
6  
Apparatus  
7  
Test Material  
8  
Hazards  
9  
Test Organisms  
10  
Sample Handling and Storage  
11  
Calibration and Standardization  
12  
Test Conditions  
13  
Interference and Limitations  
14  
Quality Assurance and Quality Control  
15  
Calculations and Interpretation of Results    
16  
Precision and Bias  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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SCOPE
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1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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