Accreditation

BioKryo has continuously improved its processes since its founding in 2010 and obtained a series of
accreditations.

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 of the German Drug Law. This approval includes drugs according to
§ 13 AMG, and serves as proof for 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

In 2013, the certification of ISO 9001:2015 for the cryostorage process had been done successfully by GZQ
“Gesellschaft zur Zertifizierung von Qualitäts- und Umweltmanagement-Systemen mbH” In 2016 BioKryo GmbH was certified after ISO 9001:2015.

AABB accredited

In 2016 the BioKryo was accredited by the AABB standard for their service of the storage of stem cells for future therapeutic applications.