Certifications

Since its founding in 2010, bioKryo has continuously improved its processes and obtained a series of accreditations.

The bioKryo-Biobanking network offers the highest standards of storage services in terms of safety, quality, reliability and traceability.

All our processes are designed to maximize sample quality as part of certified quality systems.

bioKryo-Biobanking aims to harmonize all processes and quality systems across the network, providing the same highest quality standards wherever a sample is stored. 

Our certifications

As a certified biobank, we have established a quality management system to ensure the highest quality specimens and data, while protecting the donor’s rights, including privacy and confidentiality. Validation of our processes gives stakeholders confidence in data accuracy and quality of your samples.
  • Certification iso-9001-2015

    ISO 9001:2015

    Certification for Biobanking and Bioservices
  • bioKryo freezers in German facilities

    GDP - compliant

    Good Distribution Practices
  • bioKryo italy laboratory services

    GMP - compliant

    Good Manufacturing Practices 

bioKryo France

Quality assurance system and certifications
  • Certification ISO 9001:2015
  • Certification  NFS 96-900
  • Certification ISO 20387
  • Application of good pharmaceutical practices : GMP, GCP, GCLP
  • GMO Approval
  • Respect of the BPR (Best Practices for Repositories de l’ISBER)
  • Periodic checks of the various sample security systems
  • Qualification of the equipments (QI/QO)
     

bioKryo Germany

Quality assurance system and certifications
  • German Drug Law Approval
    With the establishment of bioKryo in 2010, the local Ministry of Health provides the authorization for storage of cryopreserved samples according to § 20c and § 52a of the German Drug Law. This approval includes the cryostorage of drugs, and is proof of the GMP-compliant service of bioKryo GmbH.
  • GMO Approval
    bioKryo received approval for the storage of genetically modified organisms up to security level S2 from the Ministry of Environment of the Saarland.
  • ISO 9001:2015
    Since 2013, the certification of ISO 9001:2015 for the cryostorage process had been successfully carried out by GZQ “Gesellschaft zur Zertifizierung von Qualitäts- und Umweltmanagement-Systemen mbH”. 
  • AABB accredited
    Since 2016, bioKryo was accredited by the AABB standard for their service in storing cord blood for future therapeutic applications.

bioKryo Italy

Quality assurance system and certification
  • ISO 9001:2015 certification for both biobank and laboratories
  • Good Distribution Practices (GDP) compliant
  • Good Manufacturing Practices (GMP) compliant
  • National Transplant Center accreditation (on going)
  • GMO Approval
  • Periodic checks of the various sample security systems
  • Qualification of the equipments (QI/QO)

3cR Ressources biologiques
3CR is a network of Biological Research Centers (BRC) (biobanks, tumor libraries, etc.). It facilitates contact between researchers and research centers and has a transparent procedure that reduces response times.

POLEPHARMA
First pharmaceutical cluster in Europe. The network of excellence and innovation in the health sector. Made in France. A team of experts at the service of the network.
POLEPHARMA initiates the economic and industrial development of actors within thef French pharmaceutical and biopharmaceutical sectors via actions that promote competitiveness, innovation and attractiveness for the benefit of employment.

Alliance of German Cryobanks e. V.
bioKryo is a member of the Alliance of German Cryobanks e. V. (GDK), an association of scientific and commercial cryobanks in Germany. Within that network, BioKryo is intensely involved in sharing experiences on current topics of cryo-technology research and cryogenic safety standards.

BioDeutschland e. V.
BioDeutschland, the industry association of the German biotechnology industry, has set itself the goal to support and promote the development of an innovative economic sector based in modern life sciences.

ESBB (European, Middle Eastern & African Society for Biopreservation & Biobanking)
The ESBB (European, Middle Eastern & African Society for Biopreservation & Biobanking) deals with the collection and storage of biological materials of all types. The association is active in Europe, the Middle East and Africa. The ESBB is a charter of ISBER (International Society for Biological and Environmental Repositories).

BBMRI
BBMRI-ERIC is a European biobank research infrastructure. It unites key stakeholders in the biobanking environment  – researchers, biobankers, industry and patients  – to advance biomedical research.

Lombardy Life Sciences Cluster Association 
Lombardy’s Life Sciences Cluster is a community devoted to life sciences in the Lombardy Region. It brings together public and private players in the diagnostics, advanced therapies, pharmaceuticals, medical devices and healthcare technologies areas to foster progress in this sector in Lombardy and to create new business opportunities for its members.

FEDERCHIMICA ASSOBIOTEC 
Assobiotec, the Italian Association for the Development of Biotechnology, represents approximately 130 companies and science and technology parks operating in healthcare and bioeconomy which includes agriculture, industry and environment.