Successful AABB-reaccreditation of BioKryo GmbH (Kopie)
von Vincent v. Walcke-Wulffen
AABB (American Association of Blood Banks) reaccredits BioKryo GmbH
BioKryo GmbH as a service provider for the storage of cryopreserved samples for subsequent therapeutic and diagnostic applications is proud to announce the recertification of their storing service for stem cells according to AABB standard.
The accreditation program of the American Association of Blood Banks (AABB) assesses the highest standard of care for patients and donors in all aspects of blood banking, transfusion and cellular therapies and accredited high standards of medical, technical and administrative performance, scientific investigation, clinical application and education.
The certification of the stem cell storage bank of BioKryo GmbH by the AABB is therefore an award for the especially high quality of BioKryo service. In addition to the quality management system BioKryo the biobank facility, AABB tested the installed safety devices and the documentation of processes.
The American Association of Blood Banks established in 1947 is a professional association based in the US with the goal is to install standards in the organization of blood banks. This association has been specializing in the areas of transfusion medicine and cellular therapies based in particular on the basis of hematopoietic stem cells. The AABB is already internationally represented with members in 80 countries.
The BioKryo GmbH is a spin-off of the Fraunhofer Institute for Biomedical Engineering (IBMT) established in 2010, in which over 10 years of experience in the field of cryopreservation of e.g. cell lines or tissue was introduced. Aim of BioKryo GmbH is to carry out services of storage in a high-security environment for biotech companies as well as clinics. This is especially interesting for the back-up storage of commercially important cell lines. Therefore, BioKryo GmbH offers the storage of biological samples in the temperature ranges -20 °C, -80 °C and -150 °C. Since 2010, BioKryo GmbH owns permit pursuant §20c AMG and later §52a AMG for the storage of therapeutic samples and thus offers GMP services. Since spring 2013, BioKryo GmbH is certified to ISO 9001:2008. In spring of 2015, BioKryo was recertified to ISO 9001:2015.