QUALITY ASSURANCE 

Cytes Biotechnologies, S.L. is committed to providing researchers with high quality products and services fulfilling their needs. With this purpose, we operate quality management systems and validated processes to ensure high quality and the safety of human and animal biological products and related-services in compliance with ethical and regulatory international standards. Moreover, we also work to meet our customers’ highest expectations in terms of flexibility, expert support, delivery logistics and competitive pricing.

Quality in Cytes’ Products

All of our products are delivered in compliance of the IATA Dangerous Goods Regulations. Additionally, both our human and animal cryopreserved cells are distributed fully characterized based on their viability, morphology and adhesion results. We also ensure that our cells are tested for metabolism, induction, and transporters activity.

Human Derived Products

All of our human products are produced with the highest quality so that we accomplish all specifications and meet our customers’ needs. 

For all of our human derived products we ensure:

  • Human donors are serologically tested for infectious diseases before donations, and tested negative for HIV, Hepatitis B and C, and recently Sars-CoV-2. Moreover, complementary tests are available upon request.
  • All human products are provided with complete and anonymized medical records, allowing accessibility to donor health data (demographical information, pathology, medication, etc.) to complement research information, while ensuring donor’s privacy.
  • The adaptability of human cells to 3D culture is certified.

Human derived products are obtained and processed in accordance with Biomedical Research law 14/2007 and Royal Decree 1716/2011, which establishes the basic requirements for the authorization and operation of biobanks for the purpose of biomedical research and the treatment of biological samples of human origin, and regulates the operation and organization of the National Register of Biobanks for Biomedical Research. 

Animal Products

Our animal products are carefully prepared and fully characterized to ensure the success of your projects. All products of animal origin are processed in an EU Reference Laboratory and approved by the European Commission for Alternatives to Animal Testing (EURL ECVAM). Therefore, the quality of these products is ensured by this responsible management system.

Media

Our media is specifically formulated to ensure the cryopreservation, thawing, plating, and maintenance of cultured cells following Cytes protocols. The media should only be used for in vitro research and not for any diagnostic or therapeutic procedures. According to Regulation (EC) No 1272/2008 our media is not hazardous; however, it should be handled according to good lab practices, with proper personal protective equipment, and proper engineering controls. 

Cytes Biotechnologies Certifications

We are committed to working with our customers to meet their quality and regulatory compliance needs. Our priority is ensuring that all Cytes’ products, services, and distribution are coherent with relevant regulations. 

To accomplish our goals, we continuously implement quality improvements and can operate in compliance of several regulations and international standards.

- ISO 9001:2015 

- Good Laboratory Practice (GLP)

- Good Manufacturing Practice (GMP) 

 ISO 9001:2015
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Continuous quality improvement processes are operated

Cytes Biotechnologies, S.L. Quality Assurance will work with you to meet your quality and regulatory compliance needs.