Cytes Biotechnologies: Liver Cells for Research

Ethics & Legal

Cytes Biotechnologies, S.L. complies with all ethical standards and applicable regulations for the acquisition, handling and supply of human and animal biological products for basic research.


HUMAN

Human tissue acquisition and all the associated processes are performed in Spain according to Spanish and European legal requirements. Donor’s consent, quality, safety and traceability of the generated material are Cytes Biotechnologies, S.L.’s priorities. Donors do not receive any economical compensation. 

 

Furthermore, the isolation processes are part of an approved project by the Bioethical Committee for Clinical Research of the University of Barcelona since October 9th 2015.



APPLICABLE REGULATIONS

  • Spanish Legislation: Ley de Investigación Biomédica 14/2007, Ley de Protección de Datos y Garantía de los Derechos Digitales 13/2018, Real Decreto 1716/2011, por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica y del tratamiento de las muestras biológicas de origen humano, y se regula el funcionamiento y organización del Registro Nacional de Biobancos para investigación biomédica.

  • European Legislation: 2004/23/EC, 2006/17/EC, 2006/8/EC.
  • Ethical principles: Nüremberg Code (1946), Helsinki Declaration (2013), Belmont Report (1978) and Oviedo Convention (1997).


ANIMAL

Animal tissue acquisition and all the associated processes are performed in Germany according to German and European legal requirements.


The acquisition of animal tissue is performed under permits 3902-046-2017 and DE 13 076 0001 21 from the Landkreis Ludwigslust-Parchim, Department of Veterinary- and Foodstuff Control, in accordance with EU Regulation No. 1029/2009, Art. 17 and 23 and permit 7221.3-2-004/17 from the Ministry for Agriculture, Food Safety and Fishery of the State Mecklenburg-Pomerania in accordance with EU Regulation 2010/63/EU and with several additional regulations for the protection of animals (e.g. TierSchG dated July 18, 2016 and TierSchVerV dated August 31, 2015) used for experimentation and other scientific purposes. 



DELIVERY

Products are delivered in compliance of the IATA Dangerous Goods Regulations.