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ASTM F3142-16

(Guide)

Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs

SIGNIFICANCE AND USE
4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and suppositories (USP , USP , Ph. Eur. 2.9.3, Ph. Eur. 2.9.4). However, up to this point no pharmacopoeia standardized in-vitro release test has been established for parenteral dosage forms which provide sustained drug release, for example, implants.  
4.2 An appropriately designed in-vitro release test would be favorable in the early stage of development of biomolecule-releasing scaffolds for TEMPs, as well as in quality control, and may help to reduce the number of animal experiments.  
4.3 Appendix X1 provides a tabulated overview of published in-vitro release studies performed with biomaterial scaffolds loaded with biomolecules.  
4.4 One goal of in-vitro release studies is to simulate the in-vivo conditions as closely as possible, but with sufficiently simplifying abstraction. The simplification comprises two general aspects: the amount of fluid or release medium in contact with the implant to simulate the physiological environment, and the composition of that release medium.
SCOPE
1.1 To describe general principles of developing and/or using an in vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs, with examples from the literature  
1.2 The guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs.  
1.3 In vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions, as well as characterization, and/or quality control.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Published
Publication Date
14-Nov-2016
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Refers
ASTM F2902-16 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Dec-2016
Refers
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Dec-2016
Refers
ASTM F2312-11(2020) - Standard Terminology Relating to Tissue Engineered Medical Products
Effective Date
01-Feb-2020
Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
15-Nov-2016
Referred By
ASTM F3354-19 - Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
Effective Date
15-Nov-2016

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ASTM F3142-16 - Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPsASTM F3142-16 - Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs
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ASTM F3142-16 - Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs
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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: F3142 − 16
Standard Guide for
Evaluation of in vitro Release of Biomolecules from
1
Biomaterials Scaffolds for TEMPs
This standard is issued under the fixed designation F3142; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope USP <711> Dissolution
USP <724> Drug Release
1.1 To describe general principles of developing and/or
USP <785> Osmolality and Osmolarity
using an in vitro assay to evaluate biomolecule release from
USP <1092> The Dissolution Procedure: Development and
biomaterials scaffolds for TEMPs, with examples from the
Validation
literature
4
2.3 European Pharmacopeia (Ph. Eur.):
1.2 The guide will address scaffolds that do not contain
Ph. Eur. 2.9.3 Dissolution Test for Solid Dosage Forms
seededcells;generalprinciplesmaystillapplybutmayneedto
Ph. Eur. 2.9.4 Dissolution Test for Transdermal Patches
be modified if cells are part of the TEMPs.
Ph. Eur. 2.9.25 Dissolution Test for Medicated Chewing
1.3 In vitro release assessment of biomolecules from matri- Gums
5
ces is a valuable tool for screening biomolecule-scaffold
2.4 FDA Document:
interactions, as well as characterization, and/or quality control. FDAGuidanceforIndustry BioanalyticalMethodValidation
(2001)
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard.
3.1 ThepresentdocumentusesthedefinitionsofTerminolo-
1.5 This standard does not purport to address all of the
gies F2809 and F2312.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Significance and Use
priate safety and health practices and determine the applica-
4.1 The European Pharmacopoeia (Ph. Eur.) as well as the
bility of regulatory limitations prior to use.
UnitedStatesPharmacopeia(USP)describeseveraldissolution
and drug release setups for tablets, capsules, transdermal
2. Referenced Documents
patches and suppositories (USP <711>, USP <724>, Ph. Eur.
2
2.1 ASTM Standards:
2.9.3, Ph. Eur. 2.9.4). However, up to this point no pharmaco-
F2312 Terminology Relating to Tissue Engineered Medical
poeia standardized in-vitro release test has been established for
Products
parenteral dosage forms which provide sustained drug release,
F2809 Terminology Relating to Medical and Surgical Mate-
for example, implants.
rials and Devices
4.2 An appropriately designed in-vitro release test would be
F2902 Guide for Assessment of Absorbable Polymeric Im-
favorable in the early stage of development of biomolecule-
plants
3
releasing scaffolds for TEMPs, as well as in quality control,
2.2 United States Pharmacopeia (USP) General Chapters:
and may help to reduce the number of animal experiments.
USP<1> Injections and Implanted Drug Products
(Parenterals)—Product Quality Tests
4.3 Appendix X1 provides a tabulated overview of pub-
lished in-vitro release studies performed with biomaterial
1
scaffolds loaded with biomolecules.
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
4.4 One goal of in-vitro release studies is to simulate the
F04.42 on Biomaterials and Biomolecules for TEMPs.
in-vivo conditions as closely as possible, but with sufficiently
Current edition approved Nov. 15, 2016. Published January 2017. DOI: 10.1520/
F3142-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081
Standards volume information, refer to the standard’s Document Summary page on Strasbourg, France, or visit the website, www.edqm.eu.
5
the ASTM website. Available from Drug Information Branch (HDF-210), Center for Drug Evalu-
3
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook ation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857, or visit the
Pkwy., Rockville, MD 20852-1790, http://www.usp.org. website, http://www.fda.gov/cder/guidance/index.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3142 − 16
simplifying abstraction. The simplification comprises two gen- 5.2.4 One of the important factors is to determine if there
eral aspects: the amount of flui
...

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Sections  
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Bend  
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Hardness  
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Brinell  
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Rockwell  
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Portable  
19  
Impact  
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Keywords  
32  
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Bar Products  
Annex A1  
Tubular Products  
Annex A2  
Fasteners  
Annex A3  
Round Wire Products  
Annex A4  
Significance of Notched-Bar Impact Testing  
Annex A5  
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ASTM
ASTM C1157/C1157M-23(Specification)
Standard Performance Specification for Hydraulic Cement

SCOPE
1.1 This performance specification covers hydraulic cements for both general and special applications. There are no restrictions on the composition of the cement or its constituents (see Note 1).
Note 1: There are two related hydraulic cement standards, Specification C150/C150M for portland cement and Specifications C595/C595M for blended cements, both of which contain prescriptive and performance requirements  
1.2 This performance specification classifies cements based on specific requirements for general use, high early strength, resistance to attack by sulfates, and heat of hydration. Optional requirements are provided for the property of low reactivity with alkali-silica-reactive aggregates and for air-entraining cements.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Values in SI units [or inch-pound units] shall be obtained by measurement in SI units [or inch-pound units] or by appropriate conversion, using the Rules for Conversion and Rounding given in IEEE/ASTM SI 10, of measurements made in other units [or SI units]. Values are stated in only SI units when inch-pound units are not used in practice.  
1.4 The text of this performance specification refers to notes and footnotes that provide explanatory material. These notes and footnotes (excluding those in tables and figures) are not requirements of the standard.  
1.5 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.  
1.6 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.

  • Technical specification
    5 pages
    English language
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  • Technical specification
    5 pages
    English language
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ASTM
ASTM D6182-23(Test Method)
Standard Test Method for Flexibility and Adhesion of Finish on Leather

SIGNIFICANCE AND USE
5.1 This test method is intended for use on any type of finished leather.  
5.2 This test method will give an indication of the flexibility, adhesion, and strength of the finish on leather.
SCOPE
1.1 This test method is intended for use on finished leather to evaluate resistance to cracking, delamination, and discoloration of the finish when subjected to repeated flexing. This test method does not apply to wet blue.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.  
1.4 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.

  • Standard
    2 pages
    English language
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  • Standard
    2 pages
    English language
    sale 15% off