Instrumentation & Measurement Magazine 23-2 - 74

Towards Standardization
of Electroporation Devices
and Protocols
Aleksandra Cvetkoska, Eva Pirc, Matej Reberšek,
Ratko Magjarevic´, and Damijan Miklavcˇicˇ

C

ell exposure to high-voltage, short-duration electric pulses can lead to temporary formation of
hydrophilic pores in the plasma membrane and an
increase in the membrane's permeability which consequently
increases the transmembrane transport of molecules that are
otherwise unable to cross the membrane. This phenomenon,
termed membrane electroporation, is currently an applicable
technique in different areas such as biomedicine, biotechnology, food technology and environmental applications.
Electroporation pulses are generated by pulse power generators known as electroporators and delivered to the cells (in
tissue) via electrodes. The objective of this paper is to review
and compare characteristics of electroporation applications
and equipment described in the literature and/or present
on the market. Since there are no specific standards or regulations that specifically refer to the safety of medical devices
with intended medical uses for electroporation, we propose
guidelines for the design of clinical electroporators and define
minimal requirements for their safe and efficient use which
can be incorporated within the particular standards in the future. In order to facilitate the comparison of data obtained by
different research groups and to enable reproduction of results
under the same conditions, we want to stress the necessity of
defining the electroporator's output parameters and tolerances of electroporation parameters for electroporation-based
therapies.

Electroporation
The Biological Phenomenon
Each biological cell is protected from its surroundings by the
plasma membrane which is composed of a two-molecule thick
layer of lipids. The plasma membrane would be a mostly impenetrable barrier if there were not various proteins which
enable transport of specific molecules across the membrane.

However, cell exposure to high-voltage, short-duration electric pulses can lead to temporary formation of hydrophilic
pores in the bilayers and increase plasma membrane permeability which consequently causes increase in transmembrane
transport of molecules that are otherwise unable to cross the
membrane [1]. This phenomenon termed as membrane electroporation/permeabilization can be either reversible, when
the cell exposure to electric field is short enough for the cells
to fully recover, or irreversible, when their exposure leads to
cell death.

Electroporation Applications
Electroporation has become a relevant technique in different
areas such as biomedicine, biotechnology, food technology
and environmental applications [2]. Reversible electroporation is already a well-established method in medicine, which
combined with administration of otherwise low-permeant
chemotherapeutic drugs to tumor cells, results in highly efficient local antitumor therapy called electrochemotherapy
(ECT). Locally applied short, high-voltage (HV) pulses in the
range of few hundreds of volts to few kilovolts increase the
permeability of tumor cells membranes to facilitate cellular
uptake of chemotherapeutic drugs like bleomycin and cisplatin, thus increasing their cytotoxicity [3]. Electroporation is
also used for cell gene transfection, i.e., gene electrotransfer
(GET), which is a non-viral gene delivery method that uses
reversible electroporation for delivering DNA molecules to
cells. Skin and muscle are promising targets for gene delivery,
thus GET has been used in many medical applications, including vaccination, wound healing and cancer treatment. On
the other hand, the potential of irreversible electroporation in
medicine appeared as a nonthermal irreversible electroporation (NTIRE), also termed Pulsed Field Ablation (PFA), which
has enabled the ablation of undesirable (malignant or arrhythmogenic) tissue with minimal damage to blood vessels and

This study was conducted in the scope of the Slovenian-Croatian Cooperation in Science and Technology (BI-HR/16-17-039;
2016-2017) and supported by the Slovenian Research Agency (ARRS) (MRIC UL IP-0510, P2-0249; 2015-2020). The investment is
co-financed by the Republic of Slovenia and the European Regional Development Fund.
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April 2020
Instrumentation & Measurement Magazine 23-2

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