our standards

quality standards
ethical statement
safety and risk assessment

quality standards

Inherent variation of increasingly complex in vitro test systems as well as little guidance for routine cell culture reduce the predictive value of cell cultures. Therefore, setting common standards is of ever-increasing importance in view to the high need for comparability and reproducibility of research and development in life sciences. Therefore, standards for “Good Cell Culture Practice (GCCP)” have been put forward by leading scientists in the field, which will facilitate the inter-laboratory comparison of in vitro results.

Evercyte adheres to these GCCP standards

our cells are characterized for expression of markers and functions and show a stable of phenotype over at least 50 population doublings (PDs)

our cells grow under defined cell culture conditions whereby cell culture media and protocols are disclosed
our cells are routinely tested for freedom from contaminations (incl. bacteria, fungi and human pathogenic viruses HIV, HepA, HepB, HepC, Parvo B19)
our cells are authentic, they are tested for their STR profile (comparison with corresponding primary tissue where possible)
our cells are handled by routinely trained laboratory personnel
our cells go through a risk assessment and follow laws and regulations incl. ethical principles (see below)

Evercyte offers relevant and high-quality cell lines and in vitro bioassays that are standardized, reliable and will support the harmonization of in vitro cell culture work.

Publications: “Good Cell Culture Practice”
Coecke 2005 https://pubmed.ncbi.nlm.nih.gov/16180980

Pamies 2018 https://pubmed.ncbi.nlm.nih.gov/29697851/
Pamies 2017 https://pubmed.ncbi.nlm.nih.gov/27554434/
Publications: problem of irreproducibility / cross contaminations
Kleensang 2016 https://pubmed.ncbi.nlm.nih.gov/27456714/
Freedman 2015 https://pubmed.ncbi.nlm.nih.gov/26057340/
Horbach 2017 https://pubmed.ncbi.nlm.nih.gov/29023500/
Publications: sources of variability
Peterson 2019 https://pubmed.ncbi.nlm.nih.gov/31507156/

ethical statement

Evercyte is a biotechnology company focused on the establishment and distribution of human primary like, highly relevant continuously growing cell cultures for use in basic research as well as for the development of pre-clinical test systems, for drug screening / development or for production of extracellular vesicles / exosomes.

Therefore, Evercyte isolates cells from primary human tissues classified as surgical waste material or body fluids (e.g. urine, blood). Additionally, Evercyte also distributes highly relevant, immortalized cells licensed in from other research labs and partners.
Evercyte commits to the highest ethical and legal standards and protects the privacy and autonomy of all donors.
Evercyte has valid ethical approvals from the responsible Institutional Review Board including commercial use of established cell cultures for the setting up of in vitro bioassays as well as for production purposes. Cells are only isolated from tissues with prior given informed consent by the donor whereby the consent information includes recruitment details, the risks and benefits for the donor, strategy for data security, protection of the donor´s rights as well as information on the purpose of the donation and the potential use of the established cell cultures as in vitro test systems or production hosts. Donations are pseudonymized or anonymized and do not allow the traceability to the donor.
The Declaration of Helsinki of the World Medical Association 1964 (version 2018) https://www.wma.net/policies-post/…
The Convention for Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
(ETS No.164) https://www.coe.int/en/web/conventions/full-list/…
General Data Protection Regulation (VO 2016/679) https://eur-lex.europa.eu/eli/reg/2016/…
Austrian research specific and general legal provisions and regulations such as Data Protection Law
(DSG 2000, Datenschutz-Anpassungsgesetz 2018, DSG 2018)
https://www.ris.bka.gv.at/GeltendeFassung.wxe/…
Genetic Engineering Law (GTG, BGBl. Nr. 510/1994) https://www.ris.bka.gv.at/GeltendeFassung.wxe/…

biological safety
and risk assessment

Cells are only isolated from donors that are negative for HIV, HepB, HepC and that are clinically unremarkable. After genetic modification of isolated primary cells and subsequent life span extension, the cells are subjected to a detailed characterization including tests for expression of cell type specific markers and functions as well as for detection of viral, bacterial, fungal contaminations and authentication.

Thereafter, Evercyte performs a classification of cell lines (GMOs, genetically modified organisms) in accordance with Austrian Legislation (Gentechnikbuch; Systemverordnung) and based on recommendations of the Central Committee on Biological Safety (ZKBS).
The cells are only released for further use if considered to pose no potential hazard (biosafety level 1). The allocation to a specific risk group is indicated on the respective product data sheet.
People who work with our cells must follow national regulations and safety precautions. The laboratories must be equipped with a security level according to the classification of the cells / products. Evercyte assumes no liability whatsoever in connection with the receipt, handling or the consequences of improper use of our products.

Gentechnikbuch https://www.verbrauchergesundheit.gv.at/…

Central Committee on Biological Safety https://www.zkbs-online.de/ZKBS/DE/…
Systemverordnung https://www.ris.bka.gv.at/…

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