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Alternatives to Laboratory Animals , Vol. 30/2, pp. 219-227.
Kanafi, M., R. Pal and P. Gupta (2013), “Phenotypic and Functional Comparison of Optimum
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Leong, H. et al. (2017), “Adaptation of Human Pluripotent Stem Cells to Feeder-Free Conditions
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in Chemically Defined Medium with Enzymatic Single-Cell Passaging”, Methods in
Molecular Biology , pp. 23-37, http://dx.doi.org/10.1007/7651_2017_77 .
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Quality of Medicines & HealthCare.
Pamies, D. et al. (2016), “Good Cell Culture Practice for stem cells and stem-cell-derived
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models”, ALTEX , http://dx.doi.org/10.14573/altex.1607121 .
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van der Valk, J. (2018), “Fetal bovine serum (FBS): A commodity with high risk of
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Differentiating Neurons in a Subventricular Zone-Like Niche”, Stem Cells and Development ,
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Chapter 5. Test systems
Key message: Test systems (cells, tissues) should be well characterised and documented
to ensure the integrity and reliability of the in vitro method results.
Key content: Describes the importance of Good Cell Culture Practice (GCCP) and
guidance on sourcing, handling and maintenance of test systems, cryopreservation and
thawing, cell line identity and genetic aberrations, contaminants screening, biomarkers
and functional tests to confirm the required cell function state and metabolic activation.
Guidance for improved practice: By detailing the diversity in availability of test systems
the reader can identify for his/her work their advantages and limitations.
Recommendations are given to reduce experimental variability and increase within- and
between-laboratory reproducibility by understanding the test system you are working
with.
76 │ 5. TEST SYSTEMS
5.1. Guidance on Good Cell Culture Practice
The Good Cell Culture Practice (GCCP) guidance (Coecke et al., 2005 [1] ) was developed
to promote the maintenance of the integrity of cells in culture and to reduce the risk of
poor outcomes arising from the use of cells in vitro. The GCCP guidance is intended to
be of general use for establishing and maintaining any cell culture. The GCCP guidance
provides a set of basic principles of best practice which can be used in training new
personnel, in troubleshooting, and in ensuring the quality of laboratory work. The
guidance is also intended to assist in standardising cell and tissue culture work and to
provide a framework for the development of specific standard operating procedures (SOPs)
for the laboratory. The GCCP guidance is also applicable to stem cells (Pamies et al.,
2016 [2] ). The GCCP guidance is divided into two parts:
Principles of Good Cell Culture Practice (Annex A).
Guidance for the practical implementation of GCCP (Annex B).
The GCCP guidance is intended to be used in conjunction with other relevant guidance
documents (e.g., OECD, 2004 [3] ) and national and international regulations (e.g., EU
Directive 2004/23/EC 1 on setting standards of quality and safety for the donation,
procurement, testing, processing, preservation, storage and distribution of human tissues
and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
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- TEST SYSTEMS
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The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
The GCCP guidance is not intended to be prescriptive, but rather to provide a framework
for the development of SOPs for the laboratory. The GCCP guidance is also intended to
be used in conjunction with other relevant guidance documents (e.g., OECD, 2004 [3] )
and national and international regulations (e.g., EU Directive 2004/23/EC 1 on setting
standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells).
5.2. Cell and tissue sourcing
The source of the test system should be documented (Section 1.2). The test system should
be obtained from a reputable source, such as a recognised cell bank or a commercial
supplier, and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system,
the absence of contamination, and the functional characteristics of the test system. The
CoA should also include information on the origin of the test system, the culture history,
and any genetic modifications. The CoA should be retained as part of the study records.
The test system should be obtained from a reputable source, such as a recognised cell
bank or a commercial supplier, and should be accompanied by a certificate of analysis
(CoA) or equivalent documentation. The CoA should include information on the identity
of the test system, the absence of contamination, and the functional characteristics of the
test system. The CoA should also include information on the origin of the test system, the
culture history, and any genetic modifications. The CoA should be retained as part of the
study records.
The test system should be obtained from a reputable source, such as a recognised cell
bank or a commercial supplier, and should be accompanied by a certificate of analysis
78 │ 5. TEST SYSTEMS
(CoA) or equivalent documentation. The CoA should include information on the identity
of the test system, the absence of contamination, and the functional characteristics of the
test system. The CoA should also include information on the origin of the test system, the
culture history, and any genetic modifications. The CoA should be retained as part of the
study records.
The test system should be obtained from a reputable source, such as a recognised cell
bank or a commercial supplier, and should be accompanied by a certificate of analysis
(CoA) or equivalent documentation. The CoA should include information on the identity
of the test system, the absence of contamination, and the functional characteristics of the
test system. The CoA should also include information on the origin of the test system, the
culture history, and any genetic modifications. The CoA should be retained as part of the
study records.
The test system should be obtained from a reputable source, such as a recognised cell
bank or a commercial supplier, and should be accompanied by a certificate of analysis
(CoA) or equivalent documentation. The CoA should include information on the identity
of the test system, the absence of contamination, and the functional characteristics of the
test system. The CoA should also include information on the origin of the test system, the
culture history, and any genetic modifications. The CoA should be retained as part of the
study records.
5.3. Cell and tissue culture transportation
The test system should be transported in accordance with the supplier's instructions and
should be accompanied by a certificate of analysis (CoA) or equivalent documentation.
The CoA should include information on the identity of the test system, the absence of
contamination, and the functional characteristics of the test system. The CoA should also
include information on the origin of the test system, the culture history, and any genetic
modifications. The CoA should be retained as part of the study records.
The test system should be transported in accordance with the supplier's instructions and
should be accompanied by a certificate of analysis (CoA) or equivalent documentation.
The CoA should include information on the identity of the test system, the absence of
contamination, and the functional characteristics of the test system. The CoA should also
include information on the origin of the test system, the culture history, and any genetic
modifications. The CoA should be retained as part of the study records.
The test system should be transported in accordance with the supplier's instructions and
should be accompanied by a certificate of analysis (CoA) or equivalent documentation.
The CoA should include information on the identity of the test system, the absence of
contamination, and the functional characteristics of the test system. The CoA should also
include information on the origin of the test system, the culture history, and any genetic
modifications. The CoA should be retained as part of the study records.
5.4. Handling and maintenance of the test system
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
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- TEST SYSTEMS
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The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
Figure 5.1. Growth curve for cells grown in culture
Note: The growth curve is divided into four phases: lag phase, log phase, stationary phase, and death phase.
The lag phase is the period of time when the cells are adapting to the new environment. The log phase is the
period of time when the cells are growing exponentially. The stationary phase is the period of time when the
cells are no longer growing exponentially. The death phase is the period of time when the cells are dying.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
80 │ 5. TEST SYSTEMS
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
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- TEST SYSTEMS
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The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be handled and maintained in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
5.5. Cryopreservation and thawing
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
82 │ 5. TEST SYSTEMS
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) © OECD 2018
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The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (CoA) or equivalent
documentation. The CoA should include information on the identity of the test system, the
absence of contamination, and the functional characteristics of the test system. The CoA
should also include information on the origin of the test system, the culture history, and
any genetic modifications. The CoA should be retained as part of the study records.
The test system should be cryopreserved and thawed in accordance with the supplier's
instructions and should be accompanied by a certificate of analysis (
