ASTM E3072-22
(Terminology)Standard Terminology for Industrial Biotechnology
Standard Terminology for Industrial Biotechnology
SCOPE
1.1 This terminology is a repository for the terms, and their standardized definitions, as relates to the technical standards generated by Committee E62 on Industrial Biotechnology. The meanings and explanations of the technical terms have been written for both the nonexpert and the expert user.
1.2 At a minimum, this terminology is updated annually (at a time corresponding to the publication of the Annual Book of ASTM Standards containing this terminology standard) to include editorially any terms approved in the committee’s technical standards.
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.
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Designation: E3072 − 22
Standard Terminology for
1
Industrial Biotechnology
This standard is issued under the fixed designation E3072; 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 applied biology, n—the application of the theories and prin-
ciples of biology for practical purposes.
1.1 This terminology is a repository for the terms, and their
standardized definitions, as relates to the technical standards
biocatalyst, n—enzyme, nucleic acid, or organism capable of
generated by Committee E62 on Industrial Biotechnology. The
accelerating a chemical reaction or conversion.
meanings and explanations of the technical terms have been
biochemical, n—chemical produced by biological systems.
written for both the nonexpert and the expert user.
bioeconomy, n—the segment of the economy driven by inno-
1.2 At a minimum, this terminology is updated annually (at
vation in agriculture and biotechnology.
a time corresponding to the publication of theAnnual Book of
DISCUSSION—Focused on sustainable production of goods and ser-
ASTM Standards containing this terminology standard) to
vices from renewable and waste feedstocks.
include editorially any terms approved in the committee’s
technical standards.
bioprocess, n—a process requiring a biocatalyst.
1.3 This standard does not purport to address all of the
bioproduct, n—material or product derived from a biological
safety concerns, if any, associated with its use. It is the
source or through a biological process.
responsibility of the user of this standard to establish appro-
biorefining, v—processing systems using physical, biological
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. (for example, fermentation), chemical methods, or combina-
tions of these, by which biobased products are separated into
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard- partially or fully purified fractions, which may be further
converted into new chemical entities.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
enzyme, n—protein-based molecule that is capable of catalyz-
mendations issued by the World Trade Organization Technical
ing a chemical reaction.
Barriers to Trade (TBT) Committee.
enzyme activity, n—Catalytic activity associated with
2. Referenced Documents
enzymatically-active protein.
2
DISCUSSION—Defined as the ability to convert a given amount of
2.1 ASTM Standards:
substrate to product per unit time. Expressed as units (U) of enzyme
E2363 Terminology Relating to ProcessAnalytical Technol-
activity.
ogy in the Pharmaceutical Industry
exon, n—part of an open reading frame that encodes any part
3. Terminology
of the final gene product.
aerobic fermentation, n—fermentation processes that require
fermentation, n—the biochemical reaction process where
the presence of oxygen. (E2363)
microorganisms in a nutrient medium convert a feedstock to
a product. (E2363)
anaerobic fermentation, n—fermentation processes con-
ducted in the absence of oxygen. (E2363)
genetically engineered microorganism (GEM), n—a micro-
organism where one or more sequences of DNA has been
1
This test method is under the jurisdiction of ASTM Committee E62 on intentionally altered relative to the parent microorganism.
Industrial Biotechnology and Synthetic Biology and is the direct responsibility of
Subcommittee E62.91 on Terminology. genome, n—the sum of all genetic material within an
Current edition approved Aug. 1, 2022. Published August 2022. Originally
organism, composed of deoxyribonucleic acid (DNA) or
approved in 2017. Last previous edition approved in 2019 as E3072–19. DOI:
ribonucleic acid (RNA) arranged into sequences that direct
10.1520/E3072–22.
2 the expression and function of the proteins in the organism.
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
genome-edited organism, n—an organism containing a ge-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. nome altered through the process of genome-editing.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E3072 − 22
DISCUSSION—Gene-edited organisms can be either cisgenic or
percent of theoretical yield, n—amount of product, or
transgenic, depending on the nature
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E3072 − 19 E3072 − 22
Standard Terminology for
1
Industrial Biotechnology
This standard is issued under the fixed designation E3072; 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
1.1 This terminology is a repository for the terms, and their standardized definitions, as relates to the technical standards generated
by Committee E62 on Industrial Biotechnology. The meanings and explanations of the technical terms have been written for both
the nonexpert and the expert user.
1.2 At a minimum, this terminology is updated annually (at a time corresponding to the publication of the Annual Book of ASTM
Standards containing this terminology standard) to include editorially any terms approved in the committee’s technical standards.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
3. Terminology
aerobic fermentation, n—fermentation processes that require the presence of oxygen. (E2363)
anaerobic fermentation, n—fermentation processes conducted in the absence of oxygen. (E2363)
applied biology, n—the application of the theories and principles of biology for practical purposes.
biocatalyst, n—enzyme, nucleic acid, or organism capable of accelerating a chemical reaction or conversion.
biochemical, n—chemical produced by biological systems.
1
This test method is under the jurisdiction of ASTM Committee E62 on Industrial Biotechnology and Synthetic Biology and is the direct responsibility of Subcommittee
E62.91 on Terminology.
Current edition approved Jan. 1, 2019Aug. 1, 2022. Published March 2019August 2022. Originally approved in 2017. Last previous edition approved in 20182019 as
E3072–18.–19. DOI: 10.1520/E3072–19.10.1520/E3072–22.
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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E3072 − 22
bioeconomy, n—the segment of the economy driven by innovation in agriculture and biotechnology.
DISCUSSION—
Focused on sustainable production of goods and services from renewable and waste feedstocks.
bioprocess, n—a process requiring a biocatalyst.
bioproduct, n—material or product derived from a biological source or through a biological process.
biorefining, v—processing systems using physical, biological (for example, fermentation), chemical methods, or combinations
of these, by which biobased products are separated into partially or fully purified fractions, which may be further converted into
new chemical entities.
enzyme, n—protein-based molecule that is capable of catalyzing a chemical reaction.
enzyme activity, n—Catalytic activity associated with enzymatically-active protein.
DISCUSSION—
Defined as the ability to convert a given amount of substrate to product per unit time. Expressed as units (U) of enzyme activity.
exon, n—part of an open reading frame that encodes any part of the final gene product.
fermentation, n—the biochemical reaction process where microorganisms in a nutrient medium convert a feedstock to a
product. (E2363)
genetically engineered microorganism (GEM), n—a microorganism where one or more sequences of DNA has been
intentionally altered relative to the parent microorganism.
genome, n—the sum of all genetic material within an organism, composed of deoxyribonucleic acid (DNA) or ribonucleic acid
(RNA) arranged into sequences that direct th
...
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