One of the world's most accredited Stem Cell Bank
Future Health Biobank is one of the world’s most accredited stem cell banks. Regarded by its peers as the most innovative, highly considered centre of excellence for quality and service within the stem cell banking industry. Processes in both the UK and Swiss laboratories are licensed and accredited to the highest level and operate to GMP standards.
Future Health Biobank’s UK laboratory is a Human Tissue Bank, licensed by the Human Tissue Authority (HTA) and accredited by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK Department of Health.
The UK Department of Health was amongst the first government bodies in Europe to issue a specific Code of Practice to govern the activities of Human Tissue Banks, which includes Cord Blood Stem Cell Banks. The objective of this Code of Practice is to ensure that safe, reliable quality tissue is produced and supplied to the health service for therapeutic purposes and medical applications. It is the Gold Standard for stem cell bank operations.
AABB - American Association of Blood Banks
Future Health Biobank received AABB (American Association of Blood Banks) accreditation in 2016, facility ID number 138834, committing to ensuring quality throughout all operations.
HTA - Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended)
Future Health Biobank was licensed by the HTA in April 2006, receiving a full 3 year substantive licence on 1st September 2006, making the company the first cord blood bank to be licensed by the Human Tissue Authority (HTA). Formal licensing is only awarded following robust, lengthy and detailed audits of the company’s complete business and laboratory processes. Regular inspections ensure ongoing maintenance of the required standards to ensure continued licensing.
Future Health Biobank is regulated by the HTA and holds a licence (number 22503) granted under Regulation 7(1) and (2) and Schedule 2 of the HHuman Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) for (1) the procurement, testing, processing, distribution and/or import/export of tissues and/or cells intended for human application and (2) the storage of tissues and/or cells intended for human application.
ISO - International Standards Institute
Future Health Biobank is certified according to ISO 9001:2015, which ensures quality management systems provide the foundation to better customer satisfaction, staff motivation and continual improvement.
Future Health Biobank is certified (number FS554566) by BSI for operating a Quality Management System which complies with the requirement of ISO 9001:2015 for the scope of the procurement, storage, testing, processing, import and export, distribution and disposal of stem cells.
MHRA - Medicines and Healthcare products Regulatory Agency
Future Health Biobank is regulated by the MHRA and holds a Blood Establishment Authorisation (number BEA 21314) granted in accordance with the provisions of the Blood Safety and Quality Regulations 2005 No. 50 (as amended) to undertake the storage and distribution of blood and blood components.
OFSP - Federal Office of Public Health
Future Health Biobank received the Federal Office of Public Health’s authorisation for importation, exportation and storage of cord blood stem cells under ref OFSP No. BS2013-nTxZo93-N0-V00 & BS2013-nTxZo94-N0-V00 in December 2013.
GMP – Good Manufacturing Practice
Good Manufacturing Practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human use. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. These regulations are in accordance with the Pharmaceutical Inspection Convention/Cooperation (PIC/S) and the Directives of the European Union. Future Health Biobank received the Certificate of GMP Compliance for the manufacture of cell therapy products for autologous and allogenic use in June 2013 certificate number 16-0996.
Swissmedic authorizes Future Health Biobank’s Swiss laboratory for the import/export, processing, testing and long term cryopreservation of cord blood, cord tissue and adipose tissue for autologous and allogeneic applications. This licence regulates the manufacturing of ready to use cellular therapy products as well as intermediate cellular therapy products. Licence number 500028.